Predictive Role of Microbiome in Patients With Urothelial Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood..
- Who it may be relevant to
- Registry conditions: Urinary Bladder Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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.
Primary outcome measures
- Establish the change of microbial profile in high-grade NMIBC patients after BCG administration [Time frame: 2 years]
Secondary outcome measures (1)
- The predictive role of microbiome in BCG responsiveness [Time frame: 11 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06675656 · UROBIOTA