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

NCT00899626 | Recruiting

• 4 other identifiers: CDR0000584214P30CA068485VU-VICC-GI-0283VU-VICC-010680
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer; Gastric Cancer; Esophageal Cancer; Pancreatic Cancer; Precancerous Condition

Keywords

colon cancer; gastric cancer; pancreatic cancer; esophageal cancer; adenomatous polyp

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Vanderbilt University Medical Center patients with GI malignancy

DISEASE CHARACTERISTICS: * Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center AND * 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 PATIENT CHARACTERISTICS: * Capable of giving informed consent * Not mentally or medically impaired * No bleeding disorder PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 19914252 BACKGROUND

• 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.

  PMID: 21997556 BACKGROUND

• 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.

  PMID: 25320007 BACKGROUND

• 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.

  PMID: 27623752 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Tissue, Body Fluids

MeSH Terms

Conditions

Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Precancerous Conditions; Colonic Neoplasms; Adenomatous Polyps

Condition Hierarchy (Ancestors)

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; Esophageal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Kristen K Ciombor, MD

CONTACT

6159368422; kristen.k.ciombor@vumc.org

Keeli B Lewis, BS

CONTACT

keeli.b.lewis@vumc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: June 1, 2002
• Primary Completion (Estimated): October 1, 2045
• Study Completion (Estimated): October 1, 2045
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (2)