Urinary Bladder Cancer
Conditions
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).
Interventions
OTHERDNA 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.
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The predictive role of microbiome in BCG responsiveness | 11 years | Categorize potential candidates for BCG therapy, based on the microbiota pre-therapy. |
Contacts
Primary ContactMassimo Alfano, PhD
Backup ContactMarco Moschini, MD, PhD
Outcome results
None listed