Predictive Role of Microbiome in Patients With Urothelial Carcinoma

Launched by IRCCS SAN RAFFAELE · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the role of the microbiome, which is the collection of bacteria in our bodies, in helping predict how well patients with urinary bladder cancer will respond to certain treatments. Specifically, researchers want to see if the bacteria in urine, stool, and blood can give clues about how well patients will do with a type of immunotherapy called Bacillus Calmette-Guérin (BCG) and two different chemotherapy regimens. By understanding this relationship, they hope to create a better screening tool that could work alongside traditional tests for bladder cancer.

To participate in this study, you need to be an adult aged 18 or older with a diagnosis of non-muscle invasive bladder cancer, confirmed by a specialist. However, there are some conditions that would exclude you from the trial, such as having an ongoing urinary tract infection, recent antibiotic use, or any other major health issues that could affect your gut or bladder bacteria. If you qualify and decide to join, you can expect to provide samples of your urine, stool, and blood at different times during the study. This research is important because it might lead to more personalized and effective treatment options for bladder cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged ≥ 18 years, all able to signed informed consent form;
• • Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.
• Exclusion Criteria:
• • Participants with ongoing urinary tract infection;
• • Antibiotic treatment within the last month;
• • Immuno-/chemo- therapy within the past 3 months;
• • Chronic immunosuppressive therapy;
• • Additional major diagnosis known to affect the gut or bladder microbiota;
• • Use of probiotics;
• • Uncontrolled diabetes;
• • Participants with other malignancy or previous history of oncological or autoimmune diseases.