COLON-MD: Colon Cancer Longitudinal Study

Active, not recruiting

• Conditions: Colon Cancer

• Registration Number: NCT04751448
• Lead Sponsor: Baylor Research Institute

Brief Summary

The goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.

Detailed Description

In this longitudinal observational study patients will supply samples of their gut microbiome prior to scheduled colonoscopy or surgery along with dietary intake and blood samples; the relative abundance of microbes from those samples along with dietary data will be used to predict the presence or absence and severity of chemotherapy-induced diarrhea. Microbiome and diet based predictions from blinded samples will be combined to map the diet-microbiome changes during treatment to the changes in immune markers and risk of chemotherapy-induced diarrhea.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Colon cancer diagnosis
• Age >18 and < or equal to 79.
• Ability to perform informed consent
• FOLFOX treatment expected

Exclusion Criteria

• Not Pregnant
• Does not have Lynch syndrome or FAP diagnosis.
• Inability to perform inform consent
• inability to comply with follow up program
• history of prior colon cancer diagnosis
• previous treatment with antibiotics in the last month.
• previous bowel resection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer	3 years	Microbiome analysis from at least 112 blinded samples will be conducted from fecal samples to determine sensitivity, specificity and accuracy (reported as percentage) of a microbiome-based predictor of chemotherapy-induced diarrhea in colon cancer.

Secondary Outcome Measures

Name	Time	Method
Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer	3 years	Dietary analysis from at least 112 blinded surveys will be conducted using food frequency questionnaires (DHQ-III) plus 24 hour recalls collected during treatment to determine sensitivity, specificity and accuracy (reported as percentage) of a dietary-based predictor of chemotherapy-induced diarrhea in colon cancer.

Trial Locations

Locations (1)

Baylor Research Institute; 🇺🇸 Temple, Texas, United States