Predictive Role of Microbiome in Patients With Urothelial Carcinoma
ConditionUrinary Bladder Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Participants with ongoing urinary tract infection;
Antibiotic treatment within the last month;
Immuno-/chemo- therapy within the past 3 months;
Chronic immunosuppressive therapy;
Trial design
Treatments tested in this trial
- DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.
Treatment groups
420 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov