Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Gastrointestinal, Pancreatic Cancer
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:June 2002
End Date:October 2030

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Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

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.

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.

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
We found this trial at
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sites
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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324 Cool Springs Blvd
Nashville, Tennessee 37067
(877) 936-8422
Phone: 615-322-2391
Vanderbilt-Ingram Cancer Center - Cool Springs Vanderbilt-Ingram Cancer Center Cool Springs is a medical oncology...
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2107 Edward Curd Lane
Nashville, Tennessee 37067
615-591-9890
Phone: 615-322-2391
Vanderbilt-Ingram Cancer Center at Franklin The Vanderbilt-Ingram Cancer Center at Franklin is a free-standing radiation...
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Nashville, TN
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Nashville, Tennessee 37212
Phone: 615-327-4751
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Nashville, TN
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