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Brief Title: Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Official Title: Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
Study ID: NCT01397747
Brief Summary: The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination. The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Detailed Description: Patients who are at average risk of developing colorectal cancer who are eligible for colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC screening test and for the commercially available FIT assay. Subjects will undergo colonoscopy within 90 days of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and representative histopathology slides resulting from subsequent definitive surgery may be retrieved in order to be evaluated by central pathology to confirm diagnosis and staging.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Achieve Clinical Research, Birmingham, Alabama, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Desert Sun Clinical Research, LLC, Tucson, Arizona, United States
HealthCare Partners, Alhambra, California, United States
HealthCare Partners, Arcadia, California, United States
Valley Gastro Consultants, Arcadia, California, United States
Desert Oasis Healthcare, Bermuda Dunes, California, United States
HealthCare Partners, Burbank, California, United States
REMEK Research, Chino, California, United States
Southern California Oncology, Downey, California, United States
HealthCare Partners Medical Group, El Monte, California, United States
Southern California Oncology, Fullerton, California, United States
HealthCare Partners, Glendale, California, United States
HealthCare Partners, Glendale, California, United States
Valley Gastro Consultants, Glendora, California, United States
HealthCare Partners, Huntington Park, California, United States
Health Care Partners Medical Group, Long Beach, California, United States
Health Care Partners San Antonio, Long Beach, California, United States
VA Hospital, Long Beach, California, United States
Healthcare Partners Medical Group, Los Angeles, California, United States
HealthCare Partners, Los Angeles, California, United States
HealthCare Partners, Los Angeles, California, United States
Southern California Oncology, Lynwood, California, United States
Facey Medical Foundation, Mission Hills, California, United States
Healthcare Partners- Mission Plaza, Mission Hills, California, United States
Healthcare Partners-Mission Hills, Mission Hills, California, United States
REMEK Research, Montclair, California, United States
HealthCare Partners Medical Group, Montebello, California, United States
Furtura Research, Monterey Park, California, United States
Healthcare Partners Medical Group, Monterey Park, California, United States
Monterey Bay GI Consultants Medical Group & Research Institute, Monterey, California, United States
Diverse Research Solutions, Oxnard, California, United States
Desert Oasis Healthcare, Palm Springs, California, United States
Desert Regional Medical Center, Palm Springs, California, United States
HealthCare Partners, Pasadena, California, United States
REMEK Research, Pomona, California, United States
Health Care Partners, Redondo Beach, California, United States
Institute for Medical Research, Sacramento, California, United States
Sharp-Rees-Stealy Medical Group, San Diego, California, United States
Sharp-Rees-Stealy Medical Group, San Diego, California, United States
Sansum Clinic, Santa Barbara, California, United States
Sansum Clinic, Santa Barbara, California, United States
Santa Monica Research Institute, Santa Monica, California, United States
Health Care Partners Medical Group, Torrance, California, United States
South Bay Gastroenterology Medical Group, Torrance, California, United States
Tujunga Medical Group, Tujunga, California, United States
Healthcare Partners-Valencia, Valencia, California, United States
Healthcare Partners- Van Nuys, Van Nuys, California, United States
Southern California Oncology, Yorba Linda, California, United States
Gastroenterology Associates of Fairfield County, Bridgeport, Connecticut, United States
Gastroenterology Associates of Fairfield County, Fairfield, Connecticut, United States
Metropolitan Gastroenterology Group, PC, Washington, District of Columbia, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Melbourne GI Center, Melbourne, Florida, United States
MIMA Century Research Associates, Melbourne, Florida, United States
Suncoast Research Group, Miami, Florida, United States
GI Care Center, Miami, Florida, United States
Gastro Health P.L., Miami, Florida, United States
Miami Research Associates, South Miami, Florida, United States
Cancer Coalition of South Georgia, Albany, Georgia, United States
Phoebe Digestive Health Center, Albany, Georgia, United States
Atlanta Gastroenterology Associates, Atlanta, Georgia, United States
Atlanta Gastroenterology Associates, Atlanta, Georgia, United States
Atlanta Gastroenterology Associates, Hiram, Georgia, United States
Atlanta Gastroenterology Associates, Marietta, Georgia, United States
Atlanta Gastroenterology Associates, Marietta, Georgia, United States
Atlanta Gastroenterology Associates, Woodstock, Georgia, United States
NCH Medical Group, Arlington Heights, Illinois, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
NCH Medical Group, Buffalo Grove, Illinois, United States
Jesse Brown VAMC, Chicago, Illinois, United States
Union Health Services, Chicago, Illinois, United States
Union Health Services, Chicago, Illinois, United States
VA Hospital, Hines, Illinois, United States
Southwest Gastroenterology, New Lenox, Illinois, United States
Union Health Services, Norridge, Illinois, United States
Southwest Gastroenterology, Oak Lawn, Illinois, United States
Avicenna Clinical Research, Palos Heights, Illinois, United States
Rockford Gastroenterology Associates, LTD, Rockford, Illinois, United States
Roudebush VA Medical Center, Indianapolis, Indiana, United States
Iowa Digestive Disease Center, Clive, Iowa, United States
Gastroenterology & Nutritional Medical Services, Bastrop, Louisiana, United States
Gastroenterology Associates, Baton Rouge, Louisiana, United States
MGAGI Diagnostic and Therapeutic Center, Metairie, Louisiana, United States
New Orleans Research Institute, Metairie, Louisiana, United States
Delta Research Partners, LLC, Monroe, Louisiana, United States
Louisiana Research Center, Shreveport, Louisiana, United States
Digestive Disease Associates, PA, Baltimore, Maryland, United States
Gastrointestinal Diagnostic Center, Baltimore, Maryland, United States
Metropolitan Gastroenterology Group, Chevy Chase, Maryland, United States
Banks Hepatology Institute P.C., College Park, Maryland, United States
Digestive Disease Associates, Columbia, Maryland, United States
Howard County GIDC, Columbia, Maryland, United States
Russell Schub, Columbia, Maryland, United States
Columbia Medical Practice, Columbia, Maryland, United States
Gasro Center of Maryland, Columbia, Maryland, United States
Gastro Center of Maryland, Columbia, Maryland, United States
Centennial Medical Group, Elkridge, Maryland, United States
Gastroenterology Associates, Elkridge, Maryland, United States
CBM Pathology, Gaithersburg, Maryland, United States
Maryland Digestive Disease Center, Laurel, Maryland, United States
Gastroenterology Associates, Pasadena, Maryland, United States
Boston Medical Center: Center for Digestive Disorders, Boston, Massachusetts, United States
Boston Medical Center: Family Medicine, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Shapiro Ambulatory Care Center: Adult Primary Care, Boston, Massachusetts, United States
Shapiro Ambulatory Care Center: Women's Health Group, Boston, Massachusetts, United States
Commonwealth Clinical Studies PLLC, Brockton, Massachusetts, United States
Commonwealth Clinical Studies PLLC, East Bridgewater, Massachusetts, United States
Gastrointestinal Specialists, Taunton, Massachusetts, United States
Center for Digestive Health, Troy, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Advanced Research Institute, Reno, Nevada, United States
Summit Medical Group, Berkeley Heights, New Jersey, United States
AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey, United States
Binghamton Gastroenterology, Binghamton, New York, United States
Gastrointestinal Research Group, Great Neck, New York, United States
Mount Sinai School of Medicine, New York City, New York, United States
Faculty Practice Associates, New York, New York, United States
GI Clinic, New York, New York, United States
Internal Medicine Associates, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Practice Associates, New York, New York, United States
Digestive Health Specialists, PA, Advance, North Carolina, United States
Asheville Gastroenterology Associates, Asheville, North Carolina, United States
MediSpect, Boone, North Carolina, United States
Carolina Digestive Health Associates, Charlotte, North Carolina, United States
Carolina Digestive Health Associates, Concord, North Carolina, United States
Carolina Digestive Health Associates, Davidson, North Carolina, United States
Cumberland Research Associates, Fayetteville, North Carolina, United States
Carolina Digestive Health Associates, Harrisburg, North Carolina, United States
Digestive Health Specialists, PA, Kernersville, North Carolina, United States
Wake Research Associates, Raleigh, North Carolina, United States
Hanover Medical Specialists, Wilmington, North Carolina, United States
New Hanover Regional Medical Center, Wilmington, North Carolina, United States
Wilmington Gastroenterology Associates, Wilmington, North Carolina, United States
Digestive Health Specialists, PA, Winston-Salem, North Carolina, United States
Ohio GI & Liver Institute, Cincinnati, Ohio, United States
Consultants for Clinical Research, Cincinnati, Ohio, United States
Ohio GI & Liver Institute, Cincinnati, Ohio, United States
Northwest Gastroenterology Clinic, LLC, Portland, Oregon, United States
Main Line Gastroenterology, Bala Cynwyd, Pennsylvania, United States
Regional Gastroenterology Associates of Lancaster, Ephrata, Pennsylvania, United States
Main Line Gastroenterology, Havertown, Pennsylvania, United States
Regional Gastroenterology Associates of Lancaster, Lancaster, Pennsylvania, United States
Main Line Gastroenterology, Malvern, Pennsylvania, United States
Main Line Gastroenterology, Media, Pennsylvania, United States
Main Line Gastroenterology, Perkasie, Pennsylvania, United States
PGC Endoscopy Center Inc., Philadelphia, Pennsylvania, United States
Main Line Gastroenterology, Wynnewood, Pennsylvania, United States
Coastal Carolina Research Center, Mt. Pleasant, South Carolina, United States
Gastroenterology Associates, Bristol, Tennessee, United States
Gastro One, Germantown, Tennessee, United States
Gastroenterology Associates of Clinical Research, Kingsport, Tennessee, United States
Professional Quality Research, Inc., Austin, Texas, United States
Professional Quality Research, Inc., Austin, Texas, United States
Professional Quality Research, Inc., Austin, Texas, United States
Gastroenterology Associates, PA, Houston, Texas, United States
Advanced Clinical Research of Houston, Houston, Texas, United States
Houston Medical Research Associates, Houston, Texas, United States
Professional Quality Research, Inc., Round Rock, Texas, United States
Digestive Health Specialists of Tyler, Tyler, Texas, United States
Advanced Research Institute, Logan, Utah, United States
Advanced Research Institute, Ogden, Utah, United States
Salt Lake Research, PLLC, Salt Lake City, Utah, United States
Advanced Research Institute, Sandy, Utah, United States
Charlottesville Medical Research, Charlottesville, Virginia, United States
Gastroenterology Associates of Tidewater, Chesapeake, Virginia, United States
Blue Ridge Medical Research, Lynchburg, Virginia, United States
Digestive and Liver Disease Specialists, Norfolk, Virginia, United States
Gastroenterology Associates of Tidewater, Norfolk, Virginia, United States
Clinical Research Associates of Tidewater, Norfolk, Virginia, United States
Lakeview Medical Center, Suffolk, Virginia, United States
Gastroenterology Associates of Tidewater, Virginia Beach, Virginia, United States
Northwest Gastroenterology Associates, Bellevue, Washington, United States
Marshfield Clinic-Eau Claire Center, Eau Claire, Wisconsin, United States
University of Wisconsin Milwaukee, Franklin, Wisconsin, United States
UW Health West Clinic, Madison, Wisconsin, United States
University of Wisconsin Madison, Madison, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
University of Wisconsin Milwaukee, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Marshfield Clinic-Weston Center, Weston, Wisconsin, United States
University of Calgary, Calgary, Alberta, Canada
Alberta Health Services, Calgary, Alberta, Canada
Name: Thomas Imperiale, MD
Affiliation: Principal Study Investigator
Role: PRINCIPAL_INVESTIGATOR