Basal Tumours in Bladder Cancer, Response to chemoTherapy

• Conditions: Bladder Cancer; Chemotherapy Effect
• Interventions: Combination Product: neoadjuvant chemotherapy with cisplatine

• Registration Number: NCT04089748
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-27
• Status Verified: 2019-09
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Study First Posted: 2019-09-13
• Last Update Posted: 2019-09-13
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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-Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project.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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients from St Louis cohort not enrolled in VESPER study	neoadjuvant chemotherapy with cisplatine	Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort
Patients enrolled in VESPER study	neoadjuvant chemotherapy with cisplatine	Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort

Primary Outcome Measures

Name	Time	Method
Identifying mechanisms of resistance in basal subgroups.	through study completion, an average of 3 years
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.	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.	through study completion, an average of 3 years

Trial Locations

Locations (1)

DRCI; 🇫🇷 Rouen, France