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Bio Clinical Collection of Urothelial Carcinoma (MicroBlad)

T

Toulouse University Hospital

Status

Enrolling

Conditions

Bladder Cancer
Urothelial Carcinoma

Treatments

Biological: collection of blood, urines, stool and tumor samples

Study type

Observational

Funder types

Other

Identifiers

NCT04970472
RC31/21/0070

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

patients with Urothelial bladder carcinoma
Description:
collection of blood, urines, stool and tumor samples
Treatment:
Biological: collection of blood, urines, stool and tumor samples

Trial contacts and locations

1

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Central trial contact

Mathieu Roumiguie, MD, PhD

Data sourced from clinicaltrials.gov

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