Basal Tumours in Bladder Cancer, Response to chemoTherapy (BoBCaT)
June 2, 2025 updated by: University Hospital, Rouen
Determine the sensitivity/resistance to chemotherapy of the various subgroups of muscle-invasive bladder cancers, including the basal subgroup (about 25% of these tumours) according to 4 different classifications based on molecular or immunohistochemical classifiers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
293
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rouen, France, 76000
- DRCI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Tumors from patient having muscle invasive bladder cancer
Description
Inclusion Criteria of Patients enrolled in VESPER study:
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort and :
- having signed an informed consent form for the participation to the collection or
- dead/lost to follow-up without prior opposition expressed against research program,
- genetic analysis will only be carried out for patients who have signed the genetic consent form.
Inclusion Criteria of Patients from St Louis cohort not enrolled in VESPER study:
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort and :
- having received an informed form for the participation to the collection and not having expressed opposition against research program within 1 month or
- dead/lost to follow-up without prior opposition expressed against research program,
Exclusion Criteria:
-Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project.
OR
-Patients from St Louis not enrolled in VESPER study:Tumors from patient having expressed opposition against research program after 1 month for the participation to the collection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients enrolled in VESPER study
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort
|
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine
|
|
Patients from St Louis cohort not enrolled in VESPER study
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort
|
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identifying molecular subgroups of bladder cancer patients within VESPER and Saint-Louis cohort, who could benefit from neoadjuvant chemotherapy, taking into account the existence of different classification systems.
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Determining which classification(s) has(ve) the best ability to identifying subgroups of tumours sensitive or resistant to neoadjuvant chemotherapy.
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
|
Identifying mechanisms of resistance in basal subgroups.
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2019
Primary Completion (Actual)
April 29, 2019
Study Completion (Actual)
April 29, 2019
Study Registration Dates
First Submitted
September 4, 2019
First Submitted That Met QC Criteria
September 12, 2019
First Posted (Actual)
September 13, 2019
Study Record Updates
Last Update Posted (Actual)
June 6, 2025
Last Update Submitted That Met QC Criteria
June 2, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/384/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.