Basal Tumours in Bladder Cancer, Response to chemoTherapy

Bladder Cancer Clinical Trial

— BoBCaT  

Official title:

Basal Tumours in Bladder Cancer, Response to chemoTherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04089748
• Other study ID #: 2016/384/HP
• Status: Recruiting
• Start date: February 27, 2019
• Est. completion date: March 2023

Study information

• Verified date: September 2019
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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-Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project.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

Related Conditions & MeSH terms

• Bladder Cancer
• Chemotherapy Effect
• Urinary Bladder Neoplasms

Intervention

Combination Product:
• neoadjuvant chemotherapy with cisplatine
Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Locations

Country	Name	City	State
France	DRCI	Rouen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Rouen	APHP, Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Identifying mechanisms of resistance in basal subgroups.		through study completion, an average of 3 years