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Predictive Role of Microbiome in Patients With Urothelial Carcinoma

NCT06675656 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 420

Last updated 2024-11-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2027-11-30
Completion
2035-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06675656 on ClinicalTrials.gov