Bio Clinical Collection of Urothelial Carcinoma

Bladder Cancer Clinical Trial

— MicroBlad  

Official title:

Bio Clinical Collection of Urothelial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970472
• Other study ID #: RC31/21/0070
• Status: Recruiting
• Start date: November 16, 2021
• Est. completion date: July 14, 2031

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Mathieu Roumiguie, MD, PhD
• Phone: 561323229
• Email: roumiguie.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 14, 2031
• Est. primary completion date: July 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

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.

Locations

Country	Name	City	State
France	Rangueil University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Transcriptomic analysis	Day 0
Primary	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.	Transcriptomic, proteomic and epigenetic analysis	during the intervention/procedure/surgery