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Sponsored by: |
Vanderbilt-Ingram Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00899626 |
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.
Condition | Intervention |
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Colorectal Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer Precancerous/Nonmalignant Condition |
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 |
Study Type: | Observational |
Official Title: | Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids |
Estimated Enrollment: | 1000 |
Study Start Date: | June 2002 |
Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Nipun B Merchant 615-322-2391 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Nipun B Merchant 615-322-2391 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
Veterans Affairs Medical Center - Nashville | Recruiting |
Nashville, Tennessee, United States, 37212 | |
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas 615-327-4751 |
Study Chair: | Nipun B. Merchant | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000584214, VU-VICC-GI-0283, VU-VICC-010680 |
Study First Received: | May 9, 2009 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00899626 History of Changes |
Health Authority: | Unspecified |
colon cancer esophageal cancer gastric cancer pancreatic cancer colon cancer |
esophageal cancer gastric cancer pancreatic cancer adenomatous polyp |
Precancerous Conditions Gastrointestinal Diseases Pancreatic Neoplasms Esophageal Neoplasms Colonic Diseases Polyps Healthy Rectal Diseases Stomach Diseases Stomach Neoplasms Adenomatous Polyps Endocrine Gland Neoplasms Digestive System Neoplasms |
Endocrine System Diseases Esophageal Cancer Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Esophageal Diseases Stomach Cancer Colorectal Neoplasms |
Digestive System Neoplasms Precancerous Conditions Gastrointestinal Diseases Esophageal Neoplasms Pancreatic Neoplasms Colonic Diseases Endocrine System Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Neoplasms |
Stomach Diseases Neoplasms by Site Digestive System Diseases Head and Neck Neoplasms Stomach Neoplasms Pancreatic Diseases Gastrointestinal Neoplasms Esophageal Diseases Colorectal Neoplasms Endocrine Gland Neoplasms |