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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

This trial does not accept healthy volunteers

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 population

Adults with diagnosis of NMIBC, both first diagnosis or relapsing NMIBC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

420 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox.1 intervention
Group B: 1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox.1 intervention
Group C: 2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC.1 intervention
Group D: 2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC.1 intervention
Group E: 3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG.1 intervention
Group F: 3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG.1 intervention

Trial outcomes

Primary outcomes

1

Establish the change of microbial profile in high-grade NMIBC patients after BCG administration

Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.

Time frame
2 years

Secondary outcomes

1

The predictive role of microbiome in BCG responsiveness

Categorize potential candidates for BCG therapy, based on the microbiota pre-therapy.

Time frame
11 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: