Urothelial CarcinomaAMINCT04566029
Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas
An observational study of Urothelial Carcinoma, run by Centre Hospitalier Universitaire de Nīmes at 10 sites in France.
Trial summary
Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Blood test, Stool sample and Questionnaires
- How many people
- 40 participants
- Where
- 10 sitesFrance
- Study dates
- 12 Dec 2020to 29 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are affiliated to or covered by a health insurance scheme. All patients over the age of 18.
Who may be able to join
- For the "controls" group:
- Patients undergoing treatment for a locally advanced or metastatic urothelial tumor
- Patients who have been on immunotherapy and 2nd-line monotherapy treatment for at least 6 months for a non-operable disease
- Patients whose immunotherapy has been interrupted due to progression of the disease
- For the "cases" group:
- patients being treated in the context of a temporary authorization for use delivered for atezolizumab for the management of locally advanced or metastatic urothelial carcinomas following treatment based on platinum salts and still on treatment or patients being treated with pembrolizumab in the context of a donation for compassionate reasons (and still on treatment).
Who cannot join
- Patients who do not speak or read the French language.
- Patients in an exclusion period determined by another study.
- Patients under legal guardianship or curatorship.
- Patients for whom it is impossible to give clear information to.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
ICO-Site Paul Papin
Angers, 49055
Institut Sainte Cancerologie Lucien Neuwirth
Avignon, Saint Priest En Jarez, 42271
Institut Bergonié
Bordeaux, 33076
Centre Leon Berard
Lyon, 69373
ICM parc euromedecine
Montpellier, Hérault, 34298
Centre Antoine Lacassagne
Nice, 06189
Hopital Tenon ( Paris)
Paris, Paris Cx 20, 75970
HEGP GH Universitaire Paris Ouest
Paris, 75908
ICANS Strasbourg
Strasbourg, 67091
Iuct Oncopole
Toulouse, 31059
About this study
Official title: Analysis of the Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas According to Their Response to Immunotherapy (Responders vs. Non-responders) : A Prospective Pilot Study
Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. But only 20% of patients get any clinical benefit from these heavy treatments in the long term.
Treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. It is therefore urgent and important to exceed the current criteria for using immunotherapy. Recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy.
The investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.
- Conditions
- Urothelial Carcinoma
- Being tested
- Blood test, Stool sample, Questionnaires
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
The patients' blood will be collected in four 5mL heparinized tubes
Stool sampleBiological
The patients' stools will be collected at home
QuestionnairesOther
At each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients who have been responding to treatment for a long time Receives: Biological: Blood test; Biological: Stool sample; Other: Questionnaires | |
| Controls | Patients who do not respond to treatment Receives: Biological: Blood test; Biological: Stool sample; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool sample collected from patients in the "cases" group
Quantification of bacterial proteins as a reflection of the intestinal microbiota and human proteins in the patient's stools. These will be analyzed from 50mg of stools via mass spectrometry (ESI-Q combined with the Ultimate 3000 Nano liquid chromatography system, ThermoFisher Scientific).
Measured: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Stool sample collected from patients in the "controls" group
Quantification of bacterial proteins as a reflection of the intestinal microbiota and human proteins in the patient's stools.These will be analyzed from 50mg of stools via mass spectrometry (ESI-Q combined with the Ultimate 3000 Nano liquid chromatography system, ThermoFisher Scientific).
Measured: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Secondary outcomes (26)
Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "cases" group patients.
For each patient in the "cases" group, blood will be collected in four heparinized tubes and the immune populations will be studied via mass spectrometry (CyTOF/Helios). The frequency of the subpopulations thus determined will be compared between the two groups of patients (responders vs non responders) in order to identify those populations which are significantly different.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "controls" group patients.
For each patient in the "controls" group, blood will be collected in four heparinized tubes and the immune populations will be studied via mass spectrometry (CyTOF/Helios). The frequency of the subpopulations thus determined will be compared between the two groups of patients (responders vs non responders) in order to identify those populations which are significantly different.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
The quality of life will be evaluated via the EORTC QLQ-C30 questionnaire. The quality of life questionnaire designed by the European Organisation for Research and Treatment of Cancer known as EORTC QLQ-C30 is for all cancer patients, whatever the location of their cancer. It consists of 30 items grouped together into 15 dimensions. There are 4 possible answers to the first 28 items and 7 possible answers to the last 2 questions. The answers take the form of a Lickert scale.
Measured: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
The quality of life will be evaluated via the EORTC QLQ-C30 questionnaire. The quality of life questionnaire designed by the European Organisation for Research and Treatment of Cancer known as EORTC QLQ-C30 is for all cancer patients, whatever the location of their cancer. It consists of 30 items grouped together into 15 dimensions. There are 4 possible answers to the first 28 items and 7 possible answers to the last 2 questions. The answers take the form of a Lickert scale.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
The quality of life will be evaluated via the EORTC QLQ-C30 questionnaire. The quality of life questionnaire designed by the European Organisation for Research and Treatment of Cancer known as EORTC QLQ-C30 is for all cancer patients, whatever the location of their cancer. It consists of 30 items grouped together into 15 dimensions. There are 4 possible answers to the first 28 items and 7 possible answers to the last 2 questions. The answers take the form of a Lickert scale.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
The quality of life will be evaluated via the EORTC QLQ-C30 questionnaire. The quality of life questionnaire designed by the European Organisation for Research and Treatment of Cancer known as EORTC QLQ-C30 is for all cancer patients, whatever the location of their cancer. It consists of 30 items grouped together into 15 dimensions. There are 4 possible answers to the first 28 items and 7 possible answers to the last 2 questions. The answers take the form of a Lickert scale.
Measured: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
The quality of life will be evaluated via the EORTC QLQ-C30 questionnaire. The quality of life questionnaire designed by the European Organisation for Research and Treatment of Cancer known as EORTC QLQ-C30 is for all cancer patients, whatever the location of their cancer. It consists of 30 items grouped together into 15 dimensions. There are 4 possible answers to the first 28 items and 7 possible answers to the last 2 questions. The answers take the form of a Lickert scale.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
The quality of life will be evaluated via the EORTC QLQ-C30 questionnaire. The quality of life questionnaire designed by the European Organisation for Research and Treatment of Cancer known as EORTC QLQ-C30 is for all cancer patients, whatever the location of their cancer. It consists of 30 items grouped together into 15 dimensions. There are 4 possible answers to the first 28 items and 7 possible answers to the last 2 questions. The answers take the form of a Lickert scale.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
The EQ-5D (EuroQoL -5 Dimension) self-report questionnaire will be used to measure the quality of life under various health conditions and treatments according to 5 dimensions: mobility, personal autonomy, everyday living activities, pain/discomfort and anxiety/depression. There are 3 versions of this questionnaire: EQ-5D-3L with 3 levels of severity for each dimension, EQ-5D-5L with 5 levels of severity for each dimension and EQ-5D-Y which is the children's version. Each version is available in several languages. The questionnaire has 2 pages : page one with 5 items representing the 5 dimensions and page two with a visual analogue scale graded from 0 to 100 with 100 as the best possible state of health. For each dimension the patient must indicate what condition he/she is in. When all the answers are combined, a 5-figure number is obtained, indicating the patient's health condition. For example, the number 11111 shows that there are no problems in any of the 5 dimensions.
Measured: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
The EQ-5D (EuroQoL -5 Dimension) self-report questionnaire will be used to measure the quality of life under various health conditions and treatments according to 5 dimensions: mobility, personal autonomy, everyday living activities, pain/discomfort and anxiety/depression. There are 3 versions of this questionnaire: EQ-5D-3L with 3 levels of severity for each dimension, EQ-5D-5L with 5 levels of severity for each dimension and EQ-5D-Y which is the children's version. Each version is available in several languages. The questionnaire has 2 pages : page one with 5 items representing the 5 dimensions and page two with a visual analogue scale graded from 0 to 100 with 100 as the best possible state of health. For each dimension the patient must indicate what condition he/she is in. When all the answers are combined, a 5-figure number is obtained, indicating the patient's health condition. For example, the number 11111 shows that there are no problems in any of the 5 dimensions.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
The EQ-5D (EuroQoL -5 Dimension) self-report questionnaire will be used to measure the quality of life under various health conditions and treatments according to 5 dimensions: mobility, personal autonomy, everyday living activities, pain/discomfort and anxiety/depression. There are 3 versions of this questionnaire: EQ-5D-3L with 3 levels of severity for each dimension, EQ-5D-5L with 5 levels of severity for each dimension and EQ-5D-Y which is the children's version. Each version is available in several languages. The questionnaire has 2 pages : page one with 5 items representing the 5 dimensions and page two with a visual analogue scale graded from 0 to 100 with 100 as the best possible state of health. For each dimension the patient must indicate what condition he/she is in. When all the answers are combined, a 5-figure number is obtained, indicating the patient's health condition. For example, the number 11111 shows that there are no problems in any of the 5 dimensions.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
The EQ-5D (EuroQoL -5 Dimension) self-report questionnaire will be used to measure the quality of life under various health conditions and treatments according to 5 dimensions: mobility, personal autonomy, everyday living activities, pain/discomfort and anxiety/depression. There are 3 versions of this questionnaire: EQ-5D-3L with 3 levels of severity for each dimension, EQ-5D-5L with 5 levels of severity for each dimension and EQ-5D-Y which is the children's version. Each version is available in several languages. The questionnaire has 2 pages : page one with 5 items representing the 5 dimensions and page two with a visual analogue scale graded from 0 to 100 with 100 as the best possible state of health. For each dimension the patient must indicate what condition he/she is in. When all the answers are combined, a 5-figure number is obtained, indicating the patient's health condition. For example, the number 11111 shows that there are no problems in any of the 5 dimensions.
Measured: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
The EQ-5D (EuroQoL -5 Dimension) self-report questionnaire will be used to measure the quality of life under various health conditions and treatments according to 5 dimensions: mobility, personal autonomy, everyday living activities, pain/discomfort and anxiety/depression. There are 3 versions of this questionnaire: EQ-5D-3L with 3 levels of severity for each dimension, EQ-5D-5L with 5 levels of severity for each dimension and EQ-5D-Y which is the children's version. Each version is available in several languages. The questionnaire has 2 pages : page one with 5 items representing the 5 dimensions and page two with a visual analogue scale graded from 0 to 100 with 100 as the best possible state of health. For each dimension the patient must indicate what condition he/she is in. When all the answers are combined, a 5-figure number is obtained, indicating the patient's health condition. For example, the number 11111 shows that there are no problems in any of the 5 dimensions.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
The EQ-5D (EuroQoL -5 Dimension) self-report questionnaire will be used to measure the quality of life under various health conditions and treatments according to 5 dimensions: mobility, personal autonomy, everyday living activities, pain/discomfort and anxiety/depression. There are 3 versions of this questionnaire: EQ-5D-3L with 3 levels of severity for each dimension, EQ-5D-5L with 5 levels of severity for each dimension and EQ-5D-Y which is the children's version. Each version is available in several languages. The questionnaire has 2 pages : page one with 5 items representing the 5 dimensions and page two with a visual analogue scale graded from 0 to 100 with 100 as the best possible state of health. For each dimension the patient must indicate what condition he/she is in. When all the answers are combined, a 5-figure number is obtained, indicating the patient's health condition. For example, the number 11111 shows that there are no problems in any of the 5 dimensions.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
The NCI PRO-CTCAE (National Cancer Institute - Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale will be used to evaluate the side-effects of treatment so that they can be declared for clinical studies in cancerology. The measurement of the result is declared directly by the patient based on the last seven days of treatment. The choice of terms and the categories of toxicity depend on the adverse events targeted. A French version is available on the following link: https://healthcaredelivery.cancer.gov/pro-ctcae/countries.html. The questionnaire for this particular study will be created on the PROCTCAE website via the option "build a custom form" (https://healthcaredelivery.cancer.gov/pro-ctcae/builder.html). 20 symptoms or side effects that may occur during treatment will be selected to build a patient-reported outcomes questionnaire adapted to the study.
Measured: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
The NCI PRO-CTCAE (National Cancer Institute - Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale will be used to evaluate the side-effects of treatment so that they can be declared for clinical studies in cancerology. The measurement of the result is declared directly by the patient based on the last seven days of treatment. The choice of terms and the categories of toxicity depend on the adverse events targeted. A French version is available on the following link: https://healthcaredelivery.cancer.gov/pro-ctcae/countries.html. The questionnaire for this particular study will be created on the PROCTCAE website via the option "build a custom form" (https://healthcaredelivery.cancer.gov/pro-ctcae/builder.html). 20 symptoms or side effects that may occur during treatment will be selected to build a patient-reported outcomes questionnaire adapted to the study.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
The NCI PRO-CTCAE (National Cancer Institute - Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale will be used to evaluate the side-effects of treatment so that they can be declared for clinical studies in cancerology. The measurement of the result is declared directly by the patient based on the last seven days of treatment. The choice of terms and the categories of toxicity depend on the adverse events targeted. A French version is available on the following link: https://healthcaredelivery.cancer.gov/pro-ctcae/countries.html. The questionnaire for this particular study will be created on the PROCTCAE website via the option "build a custom form" (https://healthcaredelivery.cancer.gov/pro-ctcae/builder.html). 20 symptoms or side effects that may occur during treatment will be selected to build a patient-reported outcomes questionnaire adapted to the study.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
The NCI PRO-CTCAE (National Cancer Institute - Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale will be used to evaluate the side-effects of treatment so that they can be declared for clinical studies in cancerology. The measurement of the result is declared directly by the patient based on the last seven days of treatment. The choice of terms and the categories of toxicity depend on the adverse events targeted. A French version is available on the following link: https://healthcaredelivery.cancer.gov/pro-ctcae/countries.html. The questionnaire for this particular study will be created on the PROCTCAE website via the option "build a custom form" (https://healthcaredelivery.cancer.gov/pro-ctcae/builder.html). 20 symptoms or side effects that may occur during treatment will be selected to build a patient-reported outcomes questionnaire adapted to the study.
Measured: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
The NCI PRO-CTCAE (National Cancer Institute - Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale will be used to evaluate the side-effects of treatment so that they can be declared for clinical studies in cancerology. The measurement of the result is declared directly by the patient based on the last seven days of treatment. The choice of terms and the categories of toxicity depend on the adverse events targeted. A French version is available on the following link: https://healthcaredelivery.cancer.gov/pro-ctcae/countries.html. The questionnaire for this particular study will be created on the PROCTCAE website via the option "build a custom form" (https://healthcaredelivery.cancer.gov/pro-ctcae/builder.html). 20 symptoms or side effects that may occur during treatment will be selected to build a patient-reported outcomes questionnaire adapted to the study.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
The NCI PRO-CTCAE (National Cancer Institute - Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale will be used to evaluate the side-effects of treatment so that they can be declared for clinical studies in cancerology. The measurement of the result is declared directly by the patient based on the last seven days of treatment. The choice of terms and the categories of toxicity depend on the adverse events targeted. A French version is available on the following link: https://healthcaredelivery.cancer.gov/pro-ctcae/countries.html. The questionnaire for this particular study will be created on the PROCTCAE website via the option "build a custom form" (https://healthcaredelivery.cancer.gov/pro-ctcae/builder.html). 20 symptoms or side effects that may occur during treatment will be selected to build a patient-reported outcomes questionnaire adapted to the study.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
Version 4.03 of the NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) scale in French will be used to declare adverse events. It has 26 categories describing over 300 undesirable events, graded according to their severity (5 grades, each with its unique medical term). Grade 1 = Slight; asymptomatic or slight symptoms, only diagnosed upon clinical examination, requiring no treatment. Grade 2 = Moderate; requiring minimum local or non-invasive treatment; interfering with instrumental activities of daily living.Grade 3 = Severe or medically significant but vital prognosis is not compromised. Indication for hospitalisation or prolongation of hospitalisation, invalidating, interfering with simple activities of daily living. Grade 4 = vital prognosis compromised, requiring emergency management. Grade 5 = Death due to the adverse event. Not all grades are appropriate for all adverse events and therefore some are listed with a choice of below Grade 5.
Measured: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
Version 4.03 of the NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) scale in French will be used to declare adverse events. It has 26 categories describing over 300 undesirable events, graded according to their severity (5 grades, each with its unique medical term). Grade 1 = Slight; asymptomatic or slight symptoms, only diagnosed upon clinical examination, requiring no treatment. Grade 2 = Moderate; requiring minimum local or non-invasive treatment; interfering with instrumental activities of daily living.Grade 3 = Severe or medically significant but vital prognosis is not compromised. Indication for hospitalisation or prolongation of hospitalisation, invalidating, interfering with simple activities of daily living. Grade 4 = vital prognosis compromised, requiring emergency management. Grade 5 = Death due to the adverse event. Not all grades are appropriate for all adverse events and therefore some are listed with a choice of below Grade 5.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
Version 4.03 of the NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) scale in French will be used to declare adverse events. It has 26 categories describing over 300 undesirable events, graded according to their severity (5 grades, each with its unique medical term). Grade 1 = Slight; asymptomatic or slight symptoms, only diagnosed upon clinical examination, requiring no treatment. Grade 2 = Moderate; requiring minimum local or non-invasive treatment; interfering with instrumental activities of daily living.Grade 3 = Severe or medically significant but vital prognosis is not compromised. Indication for hospitalisation or prolongation of hospitalisation, invalidating, interfering with simple activities of daily living. Grade 4 = vital prognosis compromised, requiring emergency management. Grade 5 = Death due to the adverse event. Not all grades are appropriate for all adverse events and therefore some are listed with a choice of below Grade 5.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
Version 4.03 of the NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) scale in French will be used to declare adverse events. It has 26 categories describing over 300 undesirable events, graded according to their severity (5 grades, each with its unique medical term). Grade 1 = Slight; asymptomatic or slight symptoms, only diagnosed upon clinical examination, requiring no treatment. Grade 2 = Moderate; requiring minimum local or non-invasive treatment; interfering with instrumental activities of daily living.Grade 3 = Severe or medically significant but vital prognosis is not compromised. Indication for hospitalisation or prolongation of hospitalisation, invalidating, interfering with simple activities of daily living. Grade 4 = vital prognosis compromised, requiring emergency management. Grade 5 = Death due to the adverse event. Not all grades are appropriate for all adverse events and therefore some are listed with a choice of below Grade 5.
Measured: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
Version 4.03 of the NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) scale in French will be used to declare adverse events. It has 26 categories describing over 300 undesirable events, graded according to their severity (5 grades, each with its unique medical term). Grade 1 = Slight; asymptomatic or slight symptoms, only diagnosed upon clinical examination, requiring no treatment. Grade 2 = Moderate; requiring minimum local or non-invasive treatment; interfering with instrumental activities of daily living.Grade 3 = Severe or medically significant but vital prognosis is not compromised. Indication for hospitalisation or prolongation of hospitalisation, invalidating, interfering with simple activities of daily living. Grade 4 = vital prognosis compromised, requiring emergency management. Grade 5 = Death due to the adverse event. Not all grades are appropriate for all adverse events and therefore some are listed with a choice of below Grade 5.
Measured: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
Version 4.03 of the NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) scale in French will be used to declare adverse events. It has 26 categories describing over 300 undesirable events, graded according to their severity (5 grades, each with its unique medical term). Grade 1 = Slight; asymptomatic or slight symptoms, only diagnosed upon clinical examination, requiring no treatment. Grade 2 = Moderate; requiring minimum local or non-invasive treatment; interfering with instrumental activities of daily living.Grade 3 = Severe or medically significant but vital prognosis is not compromised. Indication for hospitalisation or prolongation of hospitalisation, invalidating, interfering with simple activities of daily living. Grade 4 = vital prognosis compromised, requiring emergency management. Grade 5 = Death due to the adverse event. Not all grades are appropriate for all adverse events and therefore some are listed with a choice of below Grade 5.
Measured: At the end of study visit, 2 months +/- 15 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start12 Dec 2020
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- European Georges Pompidou Hospital, ICM Montpellier, IUCT Oncopole (Toulouse), Institut de cancérologie Strasbourg Europe, Institut de Cancérologie Lucien Neuwirth (Saint Etienne), ICO - SITE Paul Papin, Centre Antoine Lacassagne, Institut Bergonié, Tenon Hospital, Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566029
- Sponsor's protocol ID
- NIMAO2019_2
- Other IDs
- 2020-A01224-35
- Acronym
- AMI
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Annakib S, Fiteni F, Houede N. Quality of Life with Monoclonal Antibody Therapies for Locally Advanced or Metastatic Urothelial Carcinoma: A Systematic Review. Eur Urol Oncol. 2023 Oct;6(5):467-476. doi: 10.1016/j.euo.2023.05.001. Epub 2023 May 25.
PubMed 37244802Annakib S, Di Meglio E, Dibert-Bekoy Y, Chevallier T, Roubaud G, Fournel P, Guillot A, Borchiellini D, Pouessel D, Boughalem E, Delva R, Barthelemy P, Oudard S, Thibault C, Tosi D, Houede N, Fiteni F. Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients. Cancer Med. 2025 Apr;14(8):e70896. doi: 10.1002/cam4.70896.
PubMed 40256972
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas According to Their Response to Immunotherapy (Responders vs. Non-responders) : A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04566029
- Acronym / sponsor ID
- AMI / NIMAO2019_2
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- European Georges Pompidou Hospital, ICM Montpellier, IUCT Oncopole (Toulouse), Institut de cancérologie Strasbourg Europe, Institut de Cancérologie Lucien Neuwirth (Saint Etienne), ICO - SITE Paul Papin, Centre Antoine Lacassagne, Institut Bergonié, Tenon Hospital, Paris
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. But only 20% of patients get any clinical benefit from these heavy treatments in the long term.
Treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. It is therefore urgent and important to exceed the current criteria for using immunotherapy. Recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy.
The investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: Blood test, Biological: Stool sample, Other: QuestionnairesPatients who have been responding to treatment for a long time |
| Controls | – | Biological: Blood test, Biological: Stool sample, Other: QuestionnairesPatients who do not respond to treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are affiliated to or covered by a health insurance scheme. All patients over the age of 18.
Key inclusion criteria (6 listed)
- Patients undergoing treatment for a locally advanced or metastatic urothelial tumor
- Patients who have been on immunotherapy and 2nd-line monotherapy treatment for at least 6 months for a non-operable disease
- Patients whose immunotherapy has been interrupted due to progression of the disease
- patients being treated in the context of a temporary authorization for use delivered for atezolizumab for the management of locally advanced or metastatic urothelial carcinomas following treatment based on platinum salts and still on treatment or patients being treated with pembrolizumab in the context of a donation for compassionate reasons (and still on treatment).
Key exclusion criteria (4 listed)
- Patients who do not speak or read the French language.
- Patients in an exclusion period determined by another study.
- Patients under legal guardianship or curatorship.
- Patients for whom it is impossible to give clear information to.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testThe patients' blood will be collected in four 5mL heparinized tubes | Biological | Cases, Controls |
| Stool sampleThe patients' stools will be collected at home | Biological | Cases, Controls |
| QuestionnairesAt each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE | Other | Cases, Controls |
Primary outcome
Stool sample collected from patients in the "cases" group
Time frame: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Quantification of bacterial proteins as a reflection of the intestinal microbiota and human proteins in the patient's stools. These will be analyzed from 50mg of stools via mass spectrometry (ESI-Q combined with the Ultimate 3000 Nano liquid chromatography system, ThermoFisher Scientific).
Stool sample collected from patients in the "controls" group
Time frame: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Quantification of bacterial proteins as a reflection of the intestinal microbiota and human proteins in the patient's stools.These will be analyzed from 50mg of stools via mass spectrometry (ESI-Q combined with the Ultimate 3000 Nano liquid chromatography system, ThermoFisher Scientific).
26 secondary outcomes
Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "cases" group patients.
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "controls" group patients.
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
Time frame: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
Time frame: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
Time frame: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
Time frame: At the inclusion visit on Day 0
Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
Time frame: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
Time frame: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
Time frame: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
Time frame: At the inclusion visit on Day 0
Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
Time frame: At the follow-up visit, 1 month +/- 7 days after inclusion
Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
Time frame: At the end of study visit, 2 months +/- 15 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 37244802Annakib S, Fiteni F, Houede N. Quality of Life with Monoclonal Antibody Therapies for Locally Advanced or Metastatic Urothelial Carcinoma: A Systematic Review. Eur Urol Oncol. 2023 Oct;6(5):467-476. doi: 10.1016/j.euo.2023.05.001. Epub 2023 May 25.
- Derived from this study: PubMed 40256972Annakib S, Di Meglio E, Dibert-Bekoy Y, Chevallier T, Roubaud G, Fournel P, Guillot A, Borchiellini D, Pouessel D, Boughalem E, Delva R, Barthelemy P, Oudard S, Thibault C, Tosi D, Houede N, Fiteni F. Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients. Cancer Med. 2025 Apr;14(8):e70896. doi: 10.1002/cam4.70896.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Centre Hospitalier Universitaire de Nīmes at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool sample collected from patients in the "cases" group (time frame: 24 hours before the patient's follow-up visit at 1 month +/- 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566029, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.