Clinical trial · Observational
COLON-MD: Colon Cancer Longitudinal Study
COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
NCT04751448CI-TRIAL-00101598COLON-MDrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection.
Primary outcomes (1)
- measure
- Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
- timeFrame
- 3 years
- description
- 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 outcomes (1)
- measure
- Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.