Know Cancer

or
forgot password

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Precancerous Condition

Thank you

Trial Information

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Indefinately

Safety Issue:

No

Principal Investigator

Nipun B. Merchant

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000584214

NCT ID:

NCT00899626

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Precancerous Condition
  • colon cancer
  • esophageal cancer
  • gastric cancer
  • pancreatic cancer
  • adenomatous polyp
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Precancerous Conditions

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064