MicroBlad: Bio Clinical Collection of Urothelial Carcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with Urothelial bladder carcinoma collection of blood, urines, stool and tumor samples |
Biological: collection of blood, urines, stool and tumor samples
blood, urines, stool will be collected during routine cares. Tumor samples from surgery will also be stored.
|
Outcome Measures
Primary Outcome Measures
- 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. [Day 0]
Transcriptomic analysis
- 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. [during the intervention/procedure/surgery]
Transcriptomic, proteomic and epigenetic analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult >18 years old
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Patient with suspected or diagnosed Urothelial carcinoma
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Patients who are willing to consent for this protocol.
Exclusion Criteria:
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Pregnant or breastfeeding patients
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Patients under 18 years old
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Patients under guardianship or curators
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Patients unable to sign a free and informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rangueil University Hospital | Toulouse | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Mathieu Roumiguie, MD, PhD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/21/0070