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

NCT05821582 | Withdrawn

• 1 other identifier: SAN-09391
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Primary Objective- Intestinal side effects of chemotherapy

  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.

  8 months

Interventions

Stool Collection and Survey Completion OTHER

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with active colorectal cancer

You may qualify if:

• The participant is willing and able to provide written informed consent
• The participant is willing and able to provide appropriate photo identification
• Participants aged 18 to 85, Inclusive
• Participants have been diagnosed with Active Colorectal Cancer (CRC)
• Subjects currently taking irinotecan

You may not qualify if:

• Participants who are pregnant or are nursing
• Participants with a known history of HIV, hepatitis, or other infectious diseases
• Participants who have taken an investigational product in the last 30 days
• 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
• Subjects who are currently in remission for CRC.
• Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics\*

Sponsors & Collaborators

• Sanguine Biosciences: lead

Study Sites (1)

Sanguine Biosciences, Inc.

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andrew C Frisina, M.S.

  Sanguine Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 20, 2023
• Study Start: March 27, 2023
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

US (1)