COLON-MD: Colon Cancer Longitudinal Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment

Conditions
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Colon Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage II/III colon cancer diagnosis Age >18 and < or equal to 79. Ability to perform informed consent FOLFOX treatment expected Exclusion Criteria: Not diagnosed with Stage II/III colon cancer. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 %) of a microbiome-based predictor of chemotherapy-induced diarrhea in stage II/III colon cancer. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 %) of a dietary-based predictor of chemotherapy-induced diarrhea in stage II/III colon cancer. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage II, Stage III, FOLFOX Treatment