Colon Cancer Longitudinal Study started in United States
The Baylor Research Institute is commencing recruitment for the clinical trial of the COLON-MD: Colon Cancer Longitudinal Study.
The condition is Colon Cancer.
A new clinical trial is recruiting patients in the following locations: United States.
The trial officially began on the February 1, 2021 and is planned to complete on February 1, 2025.
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.
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.
The population that can be enrolled into this study includes:
- Stage II/III colon cancer diagnosis
- Age >18 and < or equal to 79
- FOLFOX treatment expected
Patients with the following conditions:
- Not diagnosed with Stage II/III colon cancer
- Not Pregnant
- Does not have Lynch syndrome or FAP diagnosis
- history of prior colon cancer diagnosis
- previous treatment with antibiotics in the last month.
- previous bowel resection
are excluded from participation.
Baylor University is the collaborator in this clinical trial.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04751448
