Clinical trial NCT04970472: Bio Clinical Collection of Urothelial Carcinoma
Official title: Bio Clinical Collection of Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Bladder Cancer
Keywords: Urothelial Carcinoma
neoplasm
bladder cancer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be all enrolled at Toulouse University Hospital during primary cares.

Brief summary: The goal of this study is to collect tumor samples, urines, stool and blood from patients with urothelial carcinoma. These samples will be stored in a secure and confidential laboratory of the Toulouse University Hospital.

Detailed description: Recent studies have shown that the bladder also harbors friendly bacteria that are collectively called the microbiome. While the effect of the bladder microbiome to health remains to be more clearly understood, an imbalance in the microbiome is associated with several urinary diseases including overactive bladder and bladder cancer. But whether the microbiome affects the outcome of Bacille Calmette et Guérin (BCG)-immunotherapy or chemotherapy in bladder cancer is still not known.

Researchers at Toulouse University Hospital want to learn as much as possible about bladder cancer. One way to do so is by studying what is in your urines, blood, stool, saliva and in your tumor.

Patients, who will be agree to take part in this study, will have at least about one tablespoon of blood (as a residual of current biological analysis), 1 container of urines, stool and saliva collected before bladder resection.

After transurethral bladder resection or radical cystectomy scheduled as part of the standard of care, some tumor samples might be collected either as fresh tissue or as paraffin embedded tissue and store in a secure and confidential laboratory at Toulouse University Hospital.

The patient's follow up will be schedule as the standard of care and no additional visit will be required for the study. Oncological outcome of each patient will be recorded up to 5 years This is an investigational study in which up to 500 patients will take part in the collection. All patients will be all enrolled at Toulouse University Hospital.

Eligibility criteria: Inclusion Criteria:

* Adult \>18 years old
* Patient with suspected or diagnosed Urothelial carcinoma
* Patients who are willing to consent for this protocol.

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Patients under 18 years old
* Patients under guardianship or curators
* Patients unable to sign a free and informed consent

Primary outcomes:
measure: Collection and long-term collection of blood, urines, stool and tumor samples from patients with Urothelial bladder carcinoma for future biological and/or surrogate marker studies.
timeFrame: Day 0
measure: Collection and long-term collection of blood, urines, stool and tumor samples from patients with Urothelial bladder carcinoma for future biological and/or surrogate marker studies.
timeFrame: during the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Rangueil University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Mathieu Roumiguie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: