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

NCT ID: NCT05821582

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2023-10-05

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. The participant is willing and able to provide written informed consent

2. The participant is willing and able to provide appropriate photo identification

3. Participants aged 18 to 85, Inclusive

4. Participants have been diagnosed with Active Colorectal Cancer (CRC)

5. Subjects currently taking irinotecan

Exclusion:

1. Participants who are pregnant or are nursing

2. Participants with a known history of HIV, hepatitis, or other infectious diseases

3. Participants who have taken an investigational product in the last 30 days

4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

5. Subjects who are currently in remission for CRC.

• Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics*

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanguine Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew C Frisina, M.S.

Role: STUDY_DIRECTOR

Sanguine Biosciences

Locations

Sanguine Biosciences, Inc.

Woburn, Massachusetts, United States

Countries

United States

Other Identifiers

SAN-09391

Identifier Type: -

Identifier Source: org_study_id