Bio Clinical Collection of Urothelial Carcinoma (MicroBlad)

  • STATUS
    Recruiting
  • End date
    Jul 14, 2031
  • participants needed
    1000
  • sponsor
    University Hospital, Toulouse
Updated on 23 May 2022
carcinoma

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.

Details
Condition Urothelial Carcinoma, Bladder Cancer
Treatment collection of blood, urines, stool and tumor samples
Clinical Study IdentifierNCT04970472
SponsorUniversity Hospital, Toulouse
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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