Investigating the microbiome's role in predicting bladder cancer treatment response

Towards Individualization of Bladder Cancer Therapy: the Role of Microbiome in BCG Responsiveness Prediction

This study is trying to see if the bacteria in the bladder and stool of patients with early bladder cancer can help predict how well they will respond to a specific treatment called BCG therapy.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Zurich (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Baden, Aargau and 4 other locations)
• Trial ID: NCT05204199 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the microbial profiles from the bladder and feces of patients with non-muscle invasive bladder cancer (NMIBC) to predict their response to Bacillus Calmette-Guerin (BCG) therapy. By analyzing these microbial fingerprints, researchers hope to identify which patients are likely to benefit from BCG treatment before it is administered. Additionally, the study will collect various biological samples to establish a local biobank for future microbiome-related research. The findings could enhance understanding of the relationship between the microbiome and bladder cancer, potentially leading to improved treatment strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 90 diagnosed with non-muscle invasive bladder cancer who have not received recent antibiotic or immunosuppressive treatments.

Not a fit: Patients with major medical conditions affecting the gut or bladder microbiota, or those who have undergone significant gastrointestinal surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a predictive tool to identify patients who will respond to BCG therapy, thereby optimizing treatment plans.

How similar studies have performed: While the investigation of the bladder microbiome is relatively novel, similar studies exploring the gut microbiome's impact on cancer treatment have shown promising results.

Eligibility criteria

Inclusion Criteria

* Signed informed consent
* Ability to understand and follow study procedures and understand informed consent
* age 18 - 90 years

Exclusion Criteria

* Antibiotic treatment within the last month
* Immuno-/chemotherapy within the past 6 months
* Immunosuppressive therapy
* Major medical, neoplastic (with the exception of skin cancer), surgical or psychiatric condition requiring ongoing management. Minor, well-controlled conditions, such as medically controlled arterial hypertension or occupational asthma, may be present.
* Additional major diagnosis known to affect the gut or bladder microbiota (e. g. liver cirrhosis, systemic sclerosis, inflammatory bowel disease, inflammatory bowel syndrome, celiac disease, neuropathic bladder)
* Major past intestinal surgery, especially in small intestine or colon. Cholecystectomy, appendectomy, past perianal surgery or past hernia repair may be present.
* Major gastrointestinal symptoms (diarrhoea, constipation, abdominal pain, vomiting, unexplained weight loss, rectal bleeding or blood in the stool)
* Bladder augmentation surgery.
* Indwelling urinary catheter

Where this trial is running

Baden, Aargau and 4 other locations

• Kantonsspital Baden — Baden, Aargau, Switzerland (Recruiting)
• Spitalzentrum Biel — Biel, Bern, Switzerland (Not_yet_recruiting)
• Kantonsspital St. Gallen — St. Gallen, Saint Gallen, Switzerland (Recruiting)
• Kantonsspital Winterthur — Winterthur, Zürich, Switzerland (Recruiting)
• University Hospital Zürich — Zürich, Switzerland (Recruiting)

Study contacts

• Principal investigator: Cédric Poyed, MD — University Hospital Zurich, Departement of Urology
• Study coordinator: Uwe Bieri, MD

Conditions Microbiome; Bladder Cancer; BCG