Clinical trial NCT00899626: Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients
Official title: Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Precancerous Condition
Keywords: colon cancer
gastric cancer
pancreatic cancer
esophageal cancer
adenomatous polyp
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vanderbilt University Medical Center patients with GI malignancy

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients undergoing colonoscopy, endoscopy, or surgery
timeFrame: Through study completion, approximately 30 years
measure: Development of new screening strategies based on substances found in tissue and biofluid samples
timeFrame: Through study completion, approximately 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
References:
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.
citation: 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.
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.
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.