Bladder Cancer Clinical Trial
— BoBCaTOfficial title:
Basal Tumours in Bladder Cancer, Response to chemoTherapy
NCT number | NCT04089748 |
Other study ID # | 2016/384/HP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2019 |
Est. completion date | March 2023 |
Verified date | September 2019 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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expressed against research program, Exclusion Criteria: -Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project.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. |
Country | Name | City | State |
---|---|---|---|
France | DRCI | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen | APHP, Institut Curie |
France,
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 |
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