COLON-MD: Colon Cancer Longitudinal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colon Cancer. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
Overview
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.
Primary outcome measures
- Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer [Time frame: 3 years]
Secondary outcome measures (1)
- Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Baylor Research Institute — Temple
Identifiers
NCT: NCT04751448 · 017-342