Predictive Role of Microbiome in Patients With Urothelial Carcinoma

NCT ID: NCT06675656

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2035-11-30

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).

Conditions

Urinary Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox.

Predictive role of microbiome in male with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox.

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Intervention Type: OTHER

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox.

Predictive role of microbiome in female with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox.

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Intervention Type: OTHER

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC.

Predictive role of microbiome in male with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC.

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Intervention Type: OTHER

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC.

Predictive role of microbiome in female with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC.

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Intervention Type: OTHER

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG.

Predictive role of microbiome in male with high grade non-muscle invasive bladder carcinoma undergoing BCG.

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Intervention Type: OTHER

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG.

Predictive role of microbiome in female with high grade non-muscle invasive bladder carcinoma undergoing BCG.

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Intervention Type: OTHER

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

Interventions

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Massimo Alfano

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Massimo Alfano, PhD

Role: CONTACT

alfano.massimo@hsr.it

+39-022643 ext. 6351

Marco Moschini, MD, PhD

Role: CONTACT

moschini.marco@hsr.it

+39-022643 ext. 9742

Other Identifiers

UROBIOTA

Identifier Type: -

Identifier Source: org_study_id