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

Withdrawn

• 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.

Study Timeline

• Study First Submitted: 2023-03-21
• Study Start: 2023-03-27
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Status Verified: 2023-10
• Primary Completion: 2023-10-05
• Study Completion: 2023-10-05
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Trial Locations

Locations (1)

Sanguine Biosciences, Inc.; 🇺🇸 Woburn, Massachusetts, United States