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Basal Tumours in Bladder Cancer, Response to chemoTherapy (BoBCaT)

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ClinicalTrials.gov Identifier: NCT04089748
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
Institut Curie
APHP
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bladder Cancer Chemotherapy Effect Combination Product: neoadjuvant chemotherapy with cisplatine

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Basal Tumours in Bladder Cancer, Response to chemoTherapy
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Identifying mechanisms of resistance in basal subgroups. [ Time Frame: through study completion, an average of 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tumors from patient having muscle invasive bladder cancer
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089748


Locations
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France
DRCI Recruiting
Rouen, France, 76000
Contact: David MALLET    0232888265 ext +33    secretariat.drc@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Institut Curie
APHP

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04089748     History of Changes
Other Study ID Numbers: 2016/384/HP
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
neoadjuvant chemotherapy
cisplatine
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases