Role of Microbiome in BCG Responsiveness Prediction

Launched by CÉDRIC POYET · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how the bacteria in the bladder and gut can help predict how well patients with a type of bladder cancer called NMIBC will respond to a treatment called BCG. Researchers hope that by studying these microbial profiles, they can better understand which patients are likely to benefit from BCG therapy. Additionally, they plan to collect various samples, such as blood and bladder tissue, to create a biobank that can be used for future studies on the microbiome.

To participate in this trial, you need to be between 18 and 90 years old and able to provide informed consent, which means you understand the study and agree to take part. However, certain factors may exclude you, such as recent antibiotic use, ongoing treatments for serious health conditions, or specific gastrointestinal issues. If you join the trial, you will provide samples and undergo assessments to help researchers gather the information they need. This study is currently recruiting participants, and your involvement could contribute to important discoveries in cancer treatment.

Gender

ALL

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