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Bio Clinical Collection of Urothelial Carcinoma

NCT ID: NCT04970472

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-16

Study Completion Date

2031-07-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urothelial Carcinoma Bladder Cancer

Keywords

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Urothelial Carcinoma neoplasm bladder cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with Urothelial bladder carcinoma

collection of blood, urines, stool and tumor samples

collection of blood, urines, stool and tumor samples

Intervention Type BIOLOGICAL

blood, urines, stool will be collected during routine cares. Tumor samples from surgery will also be stored.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu Roumiguie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Rangueil University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathieu Roumiguie, MD, PhD

Role: CONTACT

Phone: 561323229

Email: [email protected]

Facility Contacts

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Mathieu Roumiguie, MD, PhD

Role: primary

Other Identifiers

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RC31/21/0070

Identifier Type: -

Identifier Source: org_study_id