NCT05821582

Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Sanguine Biosciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Stool Collection and Survey Completion	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. The biospecimens collected from participants on this study are stool samples.

Timeline

• Start date: 2023-03-27
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2023-04-20
• Last updated: 2023-10-12

Locations

1 site across 1 country: United States