Collection of samples from patients with bladder cancer
Bio Clinical Collection of Urothelial Carcinoma
University Hospital, Toulouse · NCT04970472
This study is collecting samples from bladder cancer patients to see how the bladder's bacteria might affect their treatment outcomes with BCG immunotherapy and chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04970472 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect tumor samples, urine, stool, and blood from patients diagnosed with urothelial carcinoma at Toulouse University Hospital. The research focuses on understanding the bladder microbiome and its potential impact on treatment outcomes for bladder cancer, particularly in relation to Bacille Calmette et Guérin (BCG) immunotherapy and chemotherapy. Participants will provide biological samples before undergoing standard surgical procedures, and their oncological outcomes will be monitored for up to five years. The study will involve approximately 500 patients and aims to enhance knowledge about bladder cancer.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with suspected or diagnosed urothelial carcinoma who are willing to consent to participate.
Not a fit: Patients who are pregnant, breastfeeding, under 18 years old, or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how the bladder microbiome influences treatment outcomes for bladder cancer patients.
How similar studies have performed: While the study's focus on the bladder microbiome is relatively novel, previous research has indicated potential links between microbiome health and various urinary diseases, suggesting a promising area of investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- Rangueil University Hospital — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Mathieu Roumiguie, MD, PhD — University Hospital, Toulouse
- Study coordinator: Mathieu Roumiguie, MD, PhD
- Email: roumiguie.m@chu-toulouse.fr
- Phone: 561323229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urothelial Carcinoma, Bladder Cancer, neoplasm, bladder cancer