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| Name | Class |
|---|---|
| Baylor University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | All patients going on study will be put in the observational grouping for blood and tissue collection with option for stool collection. |
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| 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 percentage) of a microbiome-based predictor of chemotherapy-induced diarrhea in colon cancer. | 3 years |
| 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 percentage) of a dietary-based predictor of chemotherapy-induced diarrhea in colon cancer. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Colon cancer patient, prior to surgery or prior to treatment start
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Research Institute | Recruiting | Temple | Texas | 76508 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 21, 2020 | Feb 1, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Stool sample kit, Tissue at time of surgery, blood draw(2 vials) at specific times up to 5 times.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |