RecruitingNCT05204199

Role of Microbiome in BCG Responsiveness Prediction

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

Sponsor

Cédric Poyet

Enrollment

120 participants

Start Date

Feb 22, 2022

Study Type

OBSERVATIONAL

Conditions

Bladder Cancer Microbiome

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

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

Exclusion Criteria9

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