Muscle Invasive Bladder CancerDIATRIBBENCT02648100
Basal Like Bladder Cancer : Signature and Therapeutic
An observational study of Muscle Invasive Bladder Cancer and Molecular Taxonomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Invasive Bladder Cancer, Molecular Taxonomy
- What is being tested?
- biomarker study
- How many people
- 911 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Dec 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Bladder Cancer from 4 cohorts * 2 observational cohorts of patients with muscle invasive bladder cancer (all stages) from two Henri Mondor (Créteil) and Foch (Suresnes) hospitals * 1 multicentric observational cohort of patients with locally advanced muscle invasive bladder cancer trated by adjuvantchemotherapy after cystectomy * 1 clinical trial GETUG 19 (MVAC + panitumumab)
Who may be able to join
- Muscle invasive bladder cancer Treatment by cystectomy Adjuvant chemotherapy for 3rd cohort Clinical trial GETUG 19 for 4th cohort
Who cannot join
- FFPE material not available Follow-up data not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Treatments of Basal Like Bladder Cancer (Study on Human Tumor Samples and Animal Models)
Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.
Read the detailed description
The aim of this study is:
- To validate a diagnostic test for formalin-fixed paraffin-embedded (FFPE) samples by Nanostring technology, using the 40 genes signature as reference. First, we will compare frozen and FFPE tissues (n=120), to establish a transcriptional signature in FFPE samples. Secondly, to further characterize basal subtype of bladder cancer, we will study the mutational and gain/loss landscape and immunohistochemistry markers in a new series of tumors after classifying them by our gene signature (n=510). These characteristics will be included in a new signature by defining the optimal prediction discrimination AIC et Net Reclassification Index.
- To assess the prognosis after cisplatine treatment in 510 patients treated by cystectomy with or without adjuvant chemotherapy (pT2/pT3/pT4, N0 or N+) and in another multicentric series of 188 patients treated by cystectomy and adjuvant chemotherapy (pT3/pT4 et/ou N+). Uni and multi variant analysis will be realized by adjusted Cox model, and the added value of basal subtype as compared to standard prognostic factors will be evaluated. The propensity score will be realized to assess the association of basal subtype and response to chemotherapy. The anti-EGFR response will be analyzed in the clinical trial GETUG19 which uses Panitumumab in patients with metastatic urothelial carcinomas (n=93)
- To study the treatment response in preclinical models. We characterized previously preclinical murine models derived from xenografts of MIBC (n=14 and new xenografts will be added). We will study the effect of anti-EGFR alone or in combination with chemotherapy in basal and non basal subtypes of xenografts.
By this study we will be able to better characterize the basal subtype of bladder cancer and confirm its aggressive behaviour as compared to other subtypes of MIBC. These results will further help to establish new clinical trials which include anti-EGFR in patients of basal subtype.
- Conditions
- Muscle Invasive Bladder Cancer, Molecular Taxonomy
- Being tested
- biomarker study
- Keywords
- Muscle invasive bladder cancer, Basal subtype, Anti-EGFR treatment, Nanostring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker studyOther
| Study group | Role | What they receive |
|---|---|---|
| A | 120 patients from Carte d'Identité des Tumeurs (CIT), Henri Mondor and Foch hospitals. Receives: Other: biomarker study | |
| B | 510 cystectomy patients operated between 2005 and 2010 in Henri Mondor and Foch hospitals. Receives: Other: biomarker study | |
| C | 188 patients treated by cystectomy and adjuvant chemotherapy for locally advanced bladder cancer from a national multicentric study. Receives: Other: biomarker study | |
| D | 93 patients from the clinical trial GETUG 19 (UNICANCER) Receives: Other: biomarker study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 5 years
Secondary outcomes (2)
Overall survival
Measured: 5 years
Specific survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 911 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France, Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University, Institut Curie
- Responsible party
- Sponsor
- Investigators
- Yves ALLORY, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648100
- Sponsor's protocol ID
- NI 13021
- Acronym
- DIATRIBBE
- Status last verified
- Jun 2017
- First submitted
- 5 Jan 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Treatments of Basal Like Bladder Cancer (Study on Human Tumor Samples and Animal Models)
- ClinicalTrials.gov ID
- NCT02648100
- Acronym / sponsor ID
- DIATRIBBE / NI 13021
- Conditions
- Muscle Invasive Bladder Cancer, Molecular Taxonomy
- Keywords
- Muscle invasive bladder cancer, Basal subtype, Anti-EGFR treatment, Nanostring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 911 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France, Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University, Institut Curie
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- 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.
Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.
Detailed description
The aim of this study is:
- To validate a diagnostic test for formalin-fixed paraffin-embedded (FFPE) samples by Nanostring technology, using the 40 genes signature as reference. First, we will compare frozen and FFPE tissues (n=120), to establish a transcriptional signature in FFPE samples. Secondly, to further characterize basal subtype of bladder cancer, we will study the mutational and gain/loss landscape and immunohistochemistry markers in a new series of tumors after classifying them by our gene signature (n=510). These characteristics will be included in a new signature by defining the optimal prediction discrimination AIC et Net Reclassification Index.
- To assess the prognosis after cisplatine treatment in 510 patients treated by cystectomy with or without adjuvant chemotherapy (pT2/pT3/pT4, N0 or N+) and in another multicentric series of 188 patients treated by cystectomy and adjuvant chemotherapy (pT3/pT4 et/ou N+). Uni and multi variant analysis will be realized by adjusted Cox model, and the added value of basal subtype as compared to standard prognostic factors will be evaluated. The propensity score will be realized to assess the association of basal subtype and response to chemotherapy. The anti-EGFR response will be analyzed in the clinical trial GETUG19 which uses Panitumumab in patients with metastatic urothelial carcinomas (n=93)
- To study the treatment response in preclinical models. We characterized previously preclinical murine models derived from xenografts of MIBC (n=14 and new xenografts will be added). We will study the effect of anti-EGFR alone or in combination with chemotherapy in basal and non basal subtypes of xenografts.
By this study we will be able to better characterize the basal subtype of bladder cancer and confirm its aggressive behaviour as compared to other subtypes of MIBC. These results will further help to establish new clinical trials which include anti-EGFR in patients of basal subtype.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: biomarker study120 patients from Carte d'Identité des Tumeurs (CIT), Henri Mondor and Foch hospitals. |
| B | – | Other: biomarker study510 cystectomy patients operated between 2005 and 2010 in Henri Mondor and Foch hospitals. |
| C | – | Other: biomarker study188 patients treated by cystectomy and adjuvant chemotherapy for locally advanced bladder cancer from a national multicentric study. |
| D | – | Other: biomarker study93 patients from the clinical trial GETUG 19 (UNICANCER) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Bladder Cancer from 4 cohorts * 2 observational cohorts of patients with muscle invasive bladder cancer (all stages) from two Henri Mondor (Créteil) and Foch (Suresnes) hospitals * 1 multicentric observational cohort of patients with locally advanced muscle invasive bladder cancer trated by adjuvantchemotherapy after cystectomy * 1 clinical trial GETUG 19 (MVAC + panitumumab)
Key inclusion criteria (1 listed)
- Muscle invasive bladder cancer Treatment by cystectomy Adjuvant chemotherapy for 3rd cohort Clinical trial GETUG 19 for 4th cohort
Key exclusion criteria (1 listed)
- FFPE material not available Follow-up data not available
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 |
|---|---|---|
| biomarker study | Other | A, B, C, D |
Primary outcome
Progression free survival
Time frame: 5 years
2 secondary outcomes
Overall survival
Time frame: 5 years
Specific survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: Yes
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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.
Yves ALLORY, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Muscle Invasive Bladder Cancer and Molecular Taxonomy, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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 20 Jun 2017. 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 Yves ALLORY, MD, PhD ((0)1 49 81 27 29 ext. +33, yves.allory@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 5 years). 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 20 Jun 2017.