Basal Tumours in Bladder Cancer, Response to chemoTherapy

NCT04089748 | Completed

• 1 other identifier: 2016/384/HP
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Chemotherapy Effect

Keywords

neoadjuvant chemotherapy; cisplatine

Outcome Measures

Primary Outcomes (3)

• 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

• Identifying mechanisms of resistance in basal subgroups.

  through study completion, an average of 3 years

Study Arms (2)

Patients enrolled in VESPER study

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort

Combination Product: 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

Combination Product: neoadjuvant chemotherapy with cisplatine

Interventions

neoadjuvant chemotherapy with cisplatine COMBINATION_PRODUCT

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Patients enrolled in VESPER study; Patients from St Louis cohort not enrolled in VESPER study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tumors from patient having muscle invasive bladder cancer

You may qualify if:

• 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.
• 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,

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Institut Curie: collaborator
• APHP: collaborator

Study Sites (1)

DRCI

Rouen, 76000, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 13, 2019
• Study Start: February 27, 2019
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)