Predictive Role of Microbiome in Patients With Urothelial Carcinoma

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Urinary Bladder Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT06675656

UROBIOTA

Details and patient eligibility

About

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.

Full 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).

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

420 participants in 6 patient groups

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

Description:

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

Treatment:

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.

Description:

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

Treatment:

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.

Description:

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

Treatment:

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.

Description:

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

Treatment:

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.

Description:

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

Treatment:

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.

Description:

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

Treatment:

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