Gastrointestinal Biomarkers In Tissue And Biological Fluid Samples From Colorectal Cancer Patients

Study Overview

Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy 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 participants undergoing colonoscopy, endoscopy, or surgery.

OBJECTIVES: * Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and 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 are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

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

CDR0000584214
P30CA068485 (U.S. NIH Grant/Contract)
VU-VICC-GI-0283 (OTHER Identifier) (OTHER: Vanderbilt University Medical Center)
VU-VICC-010680 (OTHER Identifier) (OTHER: Vanderbilt University Medical Center)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-27
First Submitted that Met QC Criteria 2009-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-01
First Posted (ACTUAL) 2009-05-12	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients undergoing colonoscopy, endoscopy, or surgery	Genomic and proteomic biomarkers	Through study completion, approximately 30 years
Development of new screening strategies based on substances found in tissue and biofluid samples	Genomic and proteomic biomarker discovery	Through study completion, approximately 30 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Kristen K Ciombor, MD

Phone Number: 6159368422

Email: [email protected]

Study Contact Backup

Name: Keeli B Lewis, BS

Phone Number: 6153438401

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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
Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center

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

See Disease Characteristics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Smith JJ, Deane NG, Wu F, Merchant NB, Zhang B, Jiang A, Lu P, Johnson JC, Schmidt C, Bailey CE, Eschrich S, Kis C, Levy S, Washington MK, Heslin MJ, Coffey RJ, Yeatman TJ, Shyr Y, Beauchamp RD. Experimentally derived metastasis gene expression profile predicts recurrence and death in patients with colon cancer. Gastroenterology. 2010 Mar;138(3):958-68. doi: 10.1053/j.gastro.2009.11.005. Epub 2009 Nov 13.
Oh SC, Park YY, Park ES, Lim JY, Kim SM, Kim SB, Kim J, Kim SC, Chu IS, Smith JJ, Beauchamp RD, Yeatman TJ, Kopetz S, Lee JS. Prognostic gene expression signature associated with two molecularly distinct subtypes of colorectal cancer. Gut. 2012 Sep;61(9):1291-8. doi: 10.1136/gutjnl-2011-300812. Epub 2011 Oct 13.
Tripathi MK, Deane NG, Zhu J, An H, Mima S, Wang X, Padmanabhan S, Shi Z, Prodduturi N, Ciombor KK, Chen X, Washington MK, Zhang B, Beauchamp RD. Nuclear factor of activated T-cell activity is associated with metastatic capacity in colon cancer. Cancer Res. 2014 Dec 1;74(23):6947-57. doi: 10.1158/0008-5472.CAN-14-1592. Epub 2014 Oct 15.
Zhu J, Deane NG, Lewis KB, Padmanabhan C, Washington MK, Ciombor KK, Timmers C, Goldberg RM, Beauchamp RD, Chen X. Evaluation of frozen tissue-derived prognostic gene expression signatures in FFPE colorectal cancer samples. Sci Rep. 2016 Sep 14;6:33273. doi: 10.1038/srep33273.

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Resources

Patients

Caregivers

Clinical Trial Record