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Role of Microbiome in BCG Responsiveness Prediction
RECRUITINGSponsored by Cédric Poyet
Actively Recruiting
SponsorCédric Poyet
Started2022-02-22
Est. completion2025-10-20
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05204199
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 is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.
Eligibility
Age: 18 Years – 90 YearsHealthy volunteers accepted
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
Conditions3
Bladder CancerCancerMicrobiome
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Actively Recruiting
SponsorCédric Poyet
Started2022-02-22
Est. completion2025-10-20
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05204199