COLON-MD: Colon Cancer Longitudinal Study
ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-79
SponsorBaylor Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Colon cancer diagnosis
Age >18 and < or equal to 79.
Ability to perform informed consent
FOLFOX treatment expected
Disqualifiers
Not Pregnant
Does not have Lynch syndrome or FAP diagnosis.
Inability to perform inform consent
inability to comply with follow up program
Trial population
Colon cancer patient, prior to surgery or prior to treatment start
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
11 Participants
are grouped into 1 trial groupGroup A: Observational
Trial outcomes
Primary outcomes
1
Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
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.
Time frame
3 yearsSecondary outcomes
1
Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
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.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor Research Institute
Lead sponsor
Baylor University
Collaborator
Source ClinicalTrials.gov