Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants
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- STATUS
- Recruiting
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- End date
- Oct 22, 2030
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- participants needed
- 1000
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- sponsor
- Vanderbilt University Medical Center
Summary
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy participants may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and healthy participants undergoing colonoscopy, endoscopy, or surgery.
Description
- OBJECTIVES
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- Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and healthy volunteers undergoing colonoscopy, endoscopy, or surgery.
- Develop new screening strategies based on substances found in tissue and biofluid samples.
OUTLINE: This is a multicenter study.
Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g., blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample collection. Samples are analyzed for tumor markers by proteomic methods and protein analysis. If candidate biomarkers are identified, samples are stored for future studies involving these biomarkers. Information, including demographics, personal and family history of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected from the medical record and stored in the project database.
Patients and healthy volunteers are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.
Details
| Condition | Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Precancerous Condition |
|---|---|
| Treatment | laboratory biomarker analysis, medical chart review, biologic sample preservation procedure, proteomic profiling, screening colonoscopy, protein analysis, diagnostic colonoscopy, diagnostic endoscopic procedure, diagnostic endoscopic surgery, diagnostic surgical procedure, endoscopic surgery, endoscopic surgery |
| Clinical Study Identifier | NCT00899626 |
| Sponsor | Vanderbilt University Medical Center |
| Last Modified on | 22 July 2022 |
Eligibility
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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