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

Colorectal Cancer Clinical Trial

Official title:

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899626
• Other study ID #: CDR0000584214
• Secondary ID: P30CA068485VU-VI
• Status: Recruiting
• Start date: June 2002
• Est. completion date: October 2030

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Kristen K Ciombor, MD
• Phone: 6159368422
• Email: kristen.k.ciombor[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2030
• Est. primary completion date: October 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Precancerous Condition
• Precancerous Conditions
• Stomach Neoplasms

Intervention

Genetic:
• protein analysis

• proteomic profiling

Other:
• biologic sample preservation procedure

• laboratory biomarker analysis

• medical chart review

Procedure:
• diagnostic colonoscopy

• diagnostic endoscopic procedure

• diagnostic endoscopic surgery

• diagnostic surgical procedure

• endoscopic surgery

• screening colonoscopy

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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