Colorectal Cancer Clinical Trial
Official title:
Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
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.
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. ;
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