System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Observational Not yet recruiting

NCT06675656 on ClinicalTrials.gov

Predictive Role of Microbiome in Patients With Urothelial Carcinoma

  • Sponsor: IRCCS Ospedale San Raffaele
  • Enrollment: 420 (Estimated)
  • Study start: 2024-11-01 (Estimated)
  • Primary completion: 2027-11-01 (Estimated)
  • Study completion: 2035-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Urinary Bladder Cancer

Intervention / Treatment

  • Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.

Primary Outcome Measures

  • 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.