Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Conditions
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Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Precancerous Condition

Intervention / Treatment
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* Genetic: protein analysis
* Genetic: proteomic profiling
* Other: biologic sample preservation procedure
* Other: laboratory biomarker analysis
* Other: medical chart review
* Procedure: diagnostic colonoscopy
* Procedure: diagnostic endoscopic procedure
* Procedure: diagnostic endoscopic surgery
* Procedure: diagnostic surgical procedure
* Procedure: endoscopic surgery
* Procedure: screening colonoscopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of gastrointestinal (GI) cancer, polyps, or inflammatory bowel disease History of previously treated GI cancer, polyps, or inflammatory bowel disease Healthy volunteer Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center PATIENT CHARACTERISTICS: Hemoglobin ≥ 8.0 g/dL Not pregnant Fertile participants must use effective contraception Capable of giving informed consent Not mentally or medically impaired No bleeding disorder PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: protein analysis|nan|
|Genetic: proteomic profiling|nan|
|Other: biologic sample preservation procedure|nan|
|Other: laboratory biomarker analysis|nan|
|Other: medical chart review|nan|
|Procedure: diagnostic colonoscopy|nan|
|Procedure: diagnostic endoscopic procedure|nan|
|Procedure: diagnostic endoscopic surgery|nan|
|Procedure: diagnostic surgical procedure|nan|
|Procedure: endoscopic surgery|nan|
|Procedure: screening colonoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and healthy volunteers undergoing colonoscopy, endoscopy, or surgery | Genomic and proteomic biomarkers | Indefinately | 
| Development of new screening strategies based on substances found in tissue and biofluid samples | Genomic and proteomic biomarker discovery | Indefinately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, esophageal cancer, gastric cancer, pancreatic cancer, adenomatous polyp