Continued support of the Great Lakes New England (GLNE) Clinical Validation Center (CVC) of the Early Detection Research Network (EDRN) via the U01 mechanism is requested. The GLNE CVC is a highly collaborative, multi-institutional consortium designed to develop, implement and analyze trials for the validation of biomarkers for the early detection of colorectal adenocarcinoma and other Gl malignancies. Over the last 5 years, the GLNE has developed a high quality biosample repository of samples collected from human subjects with colorectal and lower esophageal neoplasias and controls. The GLNE has preliminary characterization of 16 biomarkers for the early detection of colorectal adenocarcinoma and 3 biomarkers for the detection of progression of lower esophageal metaplasia to dysplasia and carcinoma. The GLNE has collaborated with 5 biomarker developmental laboratories, 4 biomarker reference laboratories, the EDRN DMCC, and 5 industrial partners publishing 23 manuscripts including 15 manuscripts collaborating with other EDRN centers. In the next grant period, the GLNE-CVC proposes to 1. To determine the performance of vimentin methylation, galectin-3 ligand, the Exact stool DNA panel, and fecal immunochemical test (FIT) for the early detection of colorectal neoplasia using colonoscopy as the gold standard;2. To determine if vimentin methylation, galectin-3 ligand, Exact sciences stool DNA panel, or any future individual biomarker alone performs better than fecal immunochemical testing for the detection of colorectal adenocarcinoma and high grade dysplasia;3. To determine the screening performance of vimentin methylation in stool, galectin-3 ligand, Exact sciences stool DNA panel, or any future individual biomarker or FIT together for detection of colorectal adenocarcinoma and high grade dysplasia;and 4. To establish an archive of appropriately preserved stool, serum, plasma, urine, and DNA human biospecimens to be used by EDRN investigators for future validation and biomarker discovery research.
These aims will be addressed by a multi-institutional consortium of university and community Gl practices recruiting human subjects undergoing screening colonoscopy under a PRoBE compliant protocol. The protocol requires the implementation of detailed standard operating procedures for biosample collection and management and associates these biosamples with EDRN compliant data elements. The data will be managed and analyzed by the EDRN data management and coordinating center. Biosamples will be collected for future biomarker colorectal cancer early detection validation trials and to support EDRN biomarker discovery and prevalidation.
Cancer mortality is caused by dissemination from the primary site. Through development and validation of biomarkers that signal the presence of risk or a cancer, individuals at high risk or with early stage cancers are identified. Early cancers can be removed at a curable stage, reducing cancer mortality while individuals at high risk can be monitored closely and interventions to delay or reverse the cancer process provided.
|Rho, Jung-hyun; Mead, Judson R; Wright, W Shea et al. (2014) Discovery of sialyl Lewis A and Lewis X modified protein cancer biomarkers using high density antibody arrays. J Proteomics 96:291-9|
|Zackular, Joseph P; Rogers, Mary A M; Ruffin 4th, Mack T et al. (2014) The human gut microbiome as a screening tool for colorectal cancer. Cancer Prev Res (Phila) 7:1112-21|
|Baron, John A (2012) Screening for cancer with molecular markers: progress comes with potential problems. Nat Rev Cancer 12:368-71|
|Yurgelun, Matthew B; Goel, Ajay; Hornick, Jason L et al. (2012) Microsatellite instability and DNA mismatch repair protein deficiency in Lynch syndrome colorectal polyps. Cancer Prev Res (Phila) 5:574-82|
|Yue, Tingting; Maupin, Kevin A; Fallon, Brian et al. (2011) Enhanced discrimination of malignant from benign pancreatic disease by measuring the CA 19-9 antigen on specific protein carriers. PLoS One 6:e29180|
|Li, Chen; Simeone, Diane M; Brenner, Dean E et al. (2009) Pancreatic cancer serum detection using a lectin/glyco-antibody array method. J Proteome Res 8:483-92|
|Tuck, Melissa K; Chan, Daniel W; Chia, David et al. (2009) Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res 8:113-7|
|Stoffel, Elena M; Turgeon, D Kim; Stockwell, David H et al. (2008) Chromoendoscopy detects more adenomas than colonoscopy using intensive inspection without dye spraying. Cancer Prev Res (Phila Pa) 1:507-13|
|Qiu, Yinghua; Patwa, Tasneem H; Xu, Li et al. (2008) Plasma glycoprotein profiling for colorectal cancer biomarker identification by lectin glycoarray and lectin blot. J Proteome Res 7:1693-703|
|Stoffel, Elena M; Turgeon, D Kim; Stockwell, David H et al. (2008) Missed adenomas during colonoscopic surveillance in individuals with Lynch Syndrome (hereditary nonpolyposis colorectal cancer). Cancer Prev Res (Phila Pa) 1:470-5|
Showing the most recent 10 out of 23 publications