Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
- Conditions
- Colorectal Cancer
- Registration Number
- NCT05821582
- Lead Sponsor
- Sanguine Biosciences
- Brief Summary
The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
- Detailed Description
STUDY DESIGN:
* This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows:
* Cohort 1: Colorectal Cancer: (n=8)
* The study will enroll participants per the eligibility criteria.
* Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples.
* Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective- Intestinal side effects of chemotherapy 8 months The primary objective of the study is to collect stool samples to provide to the sponsor so the sponsor can assess whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanguine Biosciences, Inc.
🇺🇸Woburn, Massachusetts, United States