Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery
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Purpose
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 |
|---|---|
|
Colorectal Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer Precancerous 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 |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids |
- 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 [ Time Frame: Indefinately ] [ Designated as safety issue: No ]
- Development of new screening strategies based on substances found in tissue and biofluid samples [ Time Frame: Indefinately ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood, Tissue, Body Fluids
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2002 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Patients with GI malignancy
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nipun B. Merchant, Professor of Surgery and Cancer Biology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00899626 History of Changes |
| Other Study ID Numbers: | CDR0000584214, P30CA068485, VU-VICC-GI-0283, VU-VICC-010680 |
| Study First Received: | May 9, 2009 |
| Last Updated: | January 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
colon cancer esophageal cancer gastric cancer pancreatic cancer adenomatous polyp |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Precancerous Conditions Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Head and Neck Neoplasms Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013