Status:
RECRUITING
Role of Microbiome in BCG Responsiveness Prediction
Lead Sponsor:
Cédric Poyet
Collaborating Sponsors:
Krebsliga Schweiz
Conditions:
Microbiome
Bladder Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration. Our second aim i...
Detailed Description
The microbiome, defined as a characteristic microbial community occupying a reasonably well-defined environment (e.g. gut microbiome), has been increasingly linked with different medical conditions an...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 20 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05204199
Start Date
February 22 2022
End Date
October 20 2025
Last Update
April 5 2024
Active Locations (5)
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1
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland, 5404
2
Spitalzentrum Biel
Biel/Bienne, Canton of Bern, Switzerland, 2501
3
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
4
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland, 8401