NCT06675656Not yet recruiting
Predictive Role of Microbiome in Patients With Urothelial Carcinoma
Source: ClinicalTrials.gov · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 420 (estimated)
- First submitted
- 4 Nov 2024
- Start date
- Nov 2024
- Primary completion date
- Nov 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Bladder cancer
- NCT number
- NCT06675656
What you commit to
- Study type: Observational
- Planned participants: 420
- From Nov 2024 to the primary completion date, Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immuno-/chemo- therapy within the past 3 months;
- Chronic immunosuppressive therapy;
- Participants with other malignancy or previous history of oncological or autoimmune diseases.
Other illness
- Participants with ongoing urinary tract infection;
- Uncontrolled diabetes;
Other
- Antibiotic treatment within the last month;
- Additional major diagnosis known to affect the gut or bladder microbiota;
- Use of probiotics;
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.