Urinary Bladder NeoplasmsCHEMOGRAMNCT06403202
Prognostic Performance of a Chemogram in Patients With Bladder Cancer.
An observational study of Urinary Bladder Neoplasms, run by Lille Catholic University at 1 site in France.
Trial summary
The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2022to 31 Aug 2024
- 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: Patients with intermediate-grade superficial bladder cancer and invasive bladder cancer
Who may be able to join
- Major patient
- Patient with suspected bladder cancer likely to be treated with chemotherapy
- Patient affiliated to a social security scheme
Who cannot join
- Insufficient tumor volume
- Patient under guardianship
- Pregnant or breast-feeding women
- Patient opposed to participation in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital St Philibert
Lomme, 59160
Jean-Louis Bonnal, bonnal.jean-louis@ghicl.net
About this study
Official title: Prognostic Performance of a Chemogram in Patients With Intermediate-grade Superficial Bladder Cancer and Invasive Bladder Cancer: Proof of Concept.
The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.
Read the detailed description
The project is based on the premise that treatments - particularly chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize treatment for each patient, while proposing an approach that is economically viable for our healthcare system. The chemogram is inspired by the principle of antibiograms, since it tests, for a given patient and in conjunction with oncologists, different chemotherapeutic or targeted treatment options based on clinical and anatomopathological data. These tests are carried out in vitro in academic research laboratories.
With this study, its proposed a "proof of concept" for the clinical use of chemograms in patients with superficial or infiltrating bladder cancer. The use of chemograms will have no impact whatsoever on the patient's treatment, which will be administered according to standard practice. Nevertheless, this study may help determine whether chemograms can detect tumor sensitivity to certain anti-cancer treatments.
In the years to come, the aim of this research work is to be able to guide the therapeutic management of patients whose tumours are resistant to the treatment envisaged (tumours with intrinsic resistance to treatment). This will avoid unnecessary treatments for the patient, often with very serious side effects.
For these two types of bladder tumour, the use of a chemogram to detect the tumour's chemosensitivity would make treatment more effective and rapid.
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Urinary Bladder Neoplasms, Chemogram
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemogram sensitivity
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating sensitivities, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Measured: 12 months
Chemogram specificity
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating specificity, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Measured: 12 months
Positive predictive value
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating positive predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Measured: 12 months
Negative predictive value
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating negative predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Measured: 12 months
Secondary outcomes (2)
Proteomic analysis
Proteomic analysis will detect various endogenous compounds: metabolites, lipids, peptides and proteins. Protein profiles (chemo-sensitive cancer, chemo-insensitive cancer, non-cancer) can be identified.
and/or transcriptomic
Measured: 12 months
Transcriptomic analysis
and/or transcriptomic
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start23 Aug 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Bonnal, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403202
- Sponsor's protocol ID
- RC-P0095
- Acronym
- CHEMOGRAM
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Performance of a Chemogram in Patients With Intermediate-grade Superficial Bladder Cancer and Invasive Bladder Cancer: Proof of Concept.
- ClinicalTrials.gov ID
- NCT06403202
- Acronym / sponsor ID
- CHEMOGRAM / RC-P0095
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Urinary Bladder Neoplasms, Chemogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 7 May 2024 (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.
The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.
Detailed description
The project is based on the premise that treatments - particularly chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize treatment for each patient, while proposing an approach that is economically viable for our healthcare system. The chemogram is inspired by the principle of antibiograms, since it tests, for a given patient and in conjunction with oncologists, different chemotherapeutic or targeted treatment options based on clinical and anatomopathological data. These tests are carried out in vitro in academic research laboratories.
With this study, its proposed a "proof of concept" for the clinical use of chemograms in patients with superficial or infiltrating bladder cancer. The use of chemograms will have no impact whatsoever on the patient's treatment, which will be administered according to standard practice. Nevertheless, this study may help determine whether chemograms can detect tumor sensitivity to certain anti-cancer treatments.
In the years to come, the aim of this research work is to be able to guide the therapeutic management of patients whose tumours are resistant to the treatment envisaged (tumours with intrinsic resistance to treatment). This will avoid unnecessary treatments for the patient, often with very serious side effects.
For these two types of bladder tumour, the use of a chemogram to detect the tumour's chemosensitivity would make treatment more effective and rapid.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate-grade superficial bladder cancer and invasive bladder cancer
Key inclusion criteria (3 listed)
- Major patient
- Patient with suspected bladder cancer likely to be treated with chemotherapy
- Patient affiliated to a social security scheme
Key exclusion criteria (4 listed)
- Insufficient tumor volume
- Patient under guardianship
- Pregnant or breast-feeding women
- Patient opposed to participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chemogram sensitivity
Time frame: 12 months
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating sensitivities, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Chemogram specificity
Time frame: 12 months
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating specificity, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Positive predictive value
Time frame: 12 months
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating positive predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
Negative predictive value
Time frame: 12 months
The relevance of the chemogram to the patient's response to treatment will be assessed by calculating negative predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.
2 secondary outcomes
Proteomic analysis
Time frame: 12 months
Transcriptomic analysis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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.
Jean-Louis Bonnal principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms, run by Lille Catholic University at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Paule Lebitasy (033 3 20 22 52 69, lebitasy.marie-paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemogram sensitivity (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.