Predictive Role of Microbiome in Patients With Urothelial Carcinoma

NCT06675656 | Not Yet Recruiting

• 1 other identifier: UROBIOTA
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Establish the change of microbial profile in high-grade NMIBC patients after BCG administration

  Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.

  2 years

Secondary Outcomes (1)

• The predictive role of microbiome in BCG responsiveness

  11 years

Study Arms (6)

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

Interventions

DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. 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.; 1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox.; 2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC.; 2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC.; 3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG.; 3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with diagnosis of NMIBC, both first diagnosis or relapsing NMIBC.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Defecation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Massimo Alfano, PhD

CONTACT

+39-022643; alfano.massimo@hsr.it

Marco Moschini, MD, PhD

CONTACT

+39-022643; moschini.marco@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2035
• Last Updated: November 5, 2024

Record last verified: 2024-11