Clinical trial · Observational
Predictive Role of Microbiome in Patients With Urothelial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- 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.
- interventionNames
- Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.
- label
- 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.
- interventionNames
- Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.
- label
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available