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NCT Number: NCT06675656

Predictive Role of Microbiome in Patients With Urothelial Carcinoma

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.

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Key information

About this study

The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

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

    Time frame: 2 years

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

Secondary outcomes

  1. The predictive role of microbiome in BCG responsiveness

    Time frame: 11 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Moschini, MD, PhD

CONTACT

[email protected]

+39-022643 ext. 9742

Massimo Alfano, PhD

CONTACT

[email protected]

+39-022643 ext. 6351

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2035
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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