Preliminary Validation of Biomarkers for the Detection of Colorectal Adenomas (Team Project #1)
- Hanash, Samir — The University of Texas MD Anderson Cancer Center
- Brenner, Dean — University of Michigan
- Lampe, Paul — Fred Hutchinson Cancer Research Center
- Srivastava, Sudhir — National Cancer Institute
- Grady UW, William — University of Washington
- Getzenberg, Robert H. — Johns Hopkins University
- Markowitz, Sanford — Case Western Reserve University
- Schoen, Robert E. — University of Pittsburgh Cancer Institute
1 AIMS We propose a GI Collaborative biomarker validation project with the goal of identifying those biomarkers developed by the GI collaborative that will predict the presence of advanced colorectal adenomas. Biomarkers from the diverse colon focused and pancreatic focused BDLs of the GI Collaborative will assay their biomarkers on sets of identical reference set samples. The GI Collaborative will also assess markers of tissue/serum-plasma and/or urine from other EDRN collaborative groups, i.e. urologic, breast, lung, in this reference set. The most promising biomarkers that meet required adenoma detection bars will be assayed in a second, blinded test set of biosamples from a separate group of subjects before being considered for inclusion in large, cross sectional biomarker validation project for the early detection of both colorectal adenocarcinomas and advanced adenomas. Aim 1 To define preliminary sensitivity, specificity, and their variance of biomarkers for the detection of advanced adenomas in a standardized, open labeled training biosample reference set. Aim 2 To select those biomarkers for the detection of advanced adenomas in the training set for additional validation in a standardized biosample reference test set using pre-set performance characteristics. Aim 3 To verify sensitivity, specificity, and their variance of biomarkers for the detection of advanced adenomas in a standardized, blinded test biosample reference set. Aim 4 To select biomarkers for the detection of advanced adenomas from the test set for inclusion in a large, cross sectional validation trial of biomarkers for the early detection of advanced adenomas. 2 BACKGROUND AND SIGNIFICANCE 2.1 Current State of the Art: Recommended Early Detection Colorectal adenocarcinoma remains the most common fatal cancer among non-smokers in the United States. Its lifetime incidence is sufficiently high at 6%, or 1 in 18, to justify population screening. It is encouraging that both colorectal cancer incidence and mortality have decreased in the past decade, developments attributed at least in part to more effective screening and surveillance (1). Wide scale screening using fecal occult blood tests results in up to a 30% reduction in colorectal adenocarcinoma (CRC) mortality, but at the expense of many colonoscopies in patients without neoplasia (2-5). Colonoscopy, while examining the complete colon, requires a thorough bowel preparation and sedation, causes patient discomfort, has a significant cost and carries a small, but non-negligible risk of complications (6-11). Patient-friendly approaches are needed with the combined features of high accuracy for cancer, high grade dysplasia, and adenomas >1cm (advanced adenomas including any tubulovillous and villous adenomas) and broad acceptability to the general population, health care providers, and third party payers (12).
There are currently no biomarkers annotated for this protocol.
No datasets are currently associated with this protocol.