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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT00899626

Collaborator

National Cancer Institute (NCI) (NIH)

1,000

Enrollment

Locations

340

Duration (Months)

250

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Study Start Date :

Jun 1, 2002

Anticipated Primary Completion Date :

Oct 1, 2030

Anticipated Study Completion Date :

Oct 1, 2030

Outcome Measures

Primary Outcome Measures

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 [Indefinately]
Genomic and proteomic biomarkers
Development of new screening strategies based on substances found in tissue and biofluid samples [Indefinately]
Genomic and proteomic biomarker discovery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
4	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838