Predictive Role of Microbiome in Patients With Urothelial Carcinoma

Not yet recruiting

• Conditions: Urinary Bladder Cancer

• Registration Number: NCT06675656
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.

In this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.

Detailed Description

The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Primary Completion: 2027-11
• Study Completion: 2035-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Adults aged ≥ 18 years, all able to signed informed consent form;
• Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.

Exclusion Criteria

• Participants with ongoing urinary tract infection;
• Antibiotic treatment within the last month;
• Immuno-/chemo- therapy within the past 3 months;
• Chronic immunosuppressive therapy;
• Additional major diagnosis known to affect the gut or bladder microbiota;
• Use of probiotics;
• Uncontrolled diabetes;
• Participants with other malignancy or previous history of oncological or autoimmune diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish the change of microbial profile in high-grade NMIBC patients after BCG administration	2 years	Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.

Secondary Outcome Measures

Name	Time	Method
The predictive role of microbiome in BCG responsiveness	11 years	Categorize potential candidates for BCG therapy, based on the microbiota pre-therapy.