Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Sensitivity and Specificity of the Exact CRC screening test with comparison to colonoscopy, both with respect to cancer.
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination.
14 Months
No
Thomas Imperiale, MD
Principal Investigator
Principal Study Investigator
United States: Food and Drug Administration
Exact Sciences 2011-01
NCT01397747
June 2011
May 2013
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mount Sinai School of Medicine | New York, New York 10029 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Boston Medical Center | Boston, Massachusetts 02118 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Gastroenterology Associates of Fairfield County | Bridgeport, Connecticut 06606 |
Asheville Gastroenterology Associates | Asheville, North Carolina 28801 |
Regional Gastroenterology Associates of Lancaster | Lancaster, Pennsylvania 17604 |
Northwest Gastroenterology Associates | Bellevue, Washington 98004 |
Atlanta Gastroenterology Associates | Atlanta, Georgia |
Professional Quality Research | Austin, Texas 78756 |
Facey Medical Foundation | Mission Hills, California 91345 |
Desert Regional Medical Center | Palm Springs, California 92262 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Mayo Clinic Rochester | Rochester, Minnesota 55905 |
Healthcare Partners Medical Group | Torrance, California 90503 |
Hanover Medical Specialists | Wilmington, North Carolina 28401 |
Wake Research Associates | Raleigh, North Carolina 27612 |
Digestive Disease Associates | Baltimore, Maryland 21229 |
Roudebush VA Medical Center | Indianapolis, Indiana |
Summit Medical Group | Summit, New Jersey 07901 |
Miami Research Associates | Miami, Florida 33173 |
University of Wisconsin Madison | Madison, Wisconsin 53792 |
Mayo Clinic Florida | Jacksonville, Florida 32224 |
Aga Clinical Research Associates, Llc | Egg Harbor Twp, New Jersey 08234 |
Consultants For Clinical Research | Cincinnati, Ohio 45219 |
Clinical Research Associates of Tidewater | Norfolk, Virginia 23507 |
Gastroenterology Associates | Kingsport, Tennessee 37660 |
Gastroenterology Associates of Tidewater | Chesapeake, Virginia 23320 |
Wilmington Gastroenterology Associates | Wilmington, North Carolina 28403 |
Centennial Medical Group | Elkridge, Maryland 21075 |
Sansum Clinic | Santa Barbara, California 93105 |
Columbia Medical Practice | Columbia, Maryland 21045 |
Houston Medical Research Associates | Houston, Texas 77090 |
Charlottesville Medical Research | Charlottesville, Virginia 22911 |
Carolina Digestive Health Associates | Harrisburg, North Carolina 28075 |
Iowa Digestive Disease Center | Clive, Iowa 50325 |
Gastroenterology Associates | Baton Rouge, Louisiana 70809 |
Center for Digestive Health | Troy, Michigan 48098 |
Digestive Health Specialists of Tyler | Tyler, Texas 75701 |
GI Care Center | Miami, Florida 33173 |
Digestive Health Specialists, PA | Winston Salem, North Carolina 27103 |
Jesse Brown VAMC | Chicago, Illinois 60612 |
Achieve Clinical Research | Birmingham, Alabama 35209 |
Rockford Gastroenterology Associates, Ltd | Rockford, Illinois 61107 |
Northwest Gastroenterology Clinic, LLC | Portland, Oregon 97208 |
Gastro One | Germantown, Tennessee 38138 |
Digestive and Liver Disease Specialists | Norfolk, Virginia 23502 |
VA Hospital | Los Angeles, California 90073 |
Coastal Carolina Research Center | Mt. Pleasant, South Carolina 29464 |
Desert Sun Clinical Research, LLC | Tucson, Arizona 85710 |
HealthCare Partners | Alhambra, California 91801 |
Valley Gastro Consultants | Arcadia, California 91006 |
Desert Oasis Healthcare | Bermuda Dunes, California 92203 |
Southern California Oncology | Downey, California 90241 |
Health Care Partners Medical Group | Long Beach, California 90806 |
Health Care Partners San Antonio | Long Beach, California 90807 |
Healthcare Partners-Mission Hills | Mission Hills, California 91345 |
Healthcare Partners- Mission Plaza | Mission Hills, California 91345 |
Monterey Bay GI Consultants Medical Group & Research Institute | Monterey, California 93940 |
Furtura Research | Monterey Park, California 91754 |
Diverse Research Solutions | Oxnard, California 93030 |
REMEK Research | Pomona, California 91767 |
Health Care Partners | Redondo Beach, California 90277 |
Institute for Medical Research | Sacramento, California 95816 |
Sharp-Rees-Stealy Medical Group | San Diego, California 92101 |
Santa Monica Research Institute | Santa Monica, California 90404 |
South Bay Gastroenterology Medical Group | Torrance, California 90505 |
Tujunga Medical Group | Tujunga, California 91042 |
Healthcare Partners-Valencia | Valencia, California 91355 |
Healthcare Partners- Van Nuys | Van Nuys, California 91405 |
Metropolitan Gastroenterology Group, PC | Washington, District of Columbia 20006 |
MIMA Century Research Associates | Melbourne, Florida 32901 |
Melbourne GI Center | Melbourne, Florida 32901 |
Suncoast Research Group | Miami, Florida 33135 |
Gastro Health P.L. | Miami, Florida 33176 |
NCH Medical Group | Arlington Heights, Illinois 60004 |
Union Health Services | Chicago, Illinois 60652 |
VA Hospital | Hines, Illinois 60141 |
Southwest Gastroenterology | New Lenox, Illinois 60451 |
Gastroenterology & Nutritional Medical Services | Bastrop, Louisiana 71220 |
New Orleans Research Institute | Metairie, Louisiana 70006 |
Delta Research Partners, LLC | Monroe, Louisiana 71201 |
Louisiana Research Center | Shreveport, Louisiana 71103 |
Digestive Disease Associates, PA | Baltimore, Maryland 21229 |
Gastrointestinal Diagnostic Center | Baltimore, Maryland 21229 |
Metropolitan Gastroenterology Group | Chevy Chase, Maryland 20815 |
Banks Hepatology Institute P.C. | College Park, Maryland 20740 |
Howard County GIDC | Columbia, Maryland 21044 |
Russell Schub | Columbia, Maryland 21044 |
Gasro Center of Maryland | Columbia, Maryland 21045 |
Gastro Center of Maryland | Columbia, Maryland 21045 |
Gastroenterology Associates | Elkridge, Maryland 21075 |
CBM Pathology | Gaithersburg, Maryland 20879 |
Maryland Digestive Disease Center | Laurel, Maryland 20707 |
Shapiro Ambulatory Care Center: Women's Health Group | Boston, Massachusetts 02118 |
Shapiro Ambulatory Care Center: Adult Primary Care | Boston, Massachusetts 02118 |
Boston Medical Center: Family Medicine | Boston, Massachusetts 02118 |
Boston Medical Center: Center for Digestive Disorders | Boston, Massachusetts 02118 |
Commonwealth Clinical Studies PLLC | Brockton, Massachusetts 02302 |
Advanced Research Institute | Reno, Nevada 89511 |
Binghamton Gastroenterology | Binghamton, New York 13903 |
Gastrointestinal Research Group | Great Neck, New York 11023 |
MediSpect | Boone, North Carolina 28607 |
Cumberland Research Associates | Fayetteville, North Carolina 28304 |
Ohio GI & Liver Institute | Cincinnati, Ohio 45219 |
Main Line Gastroenterology | Bala Cynwyd, Pennsylvania 19004 |
PGC Endoscopy Center Inc. | Philadelphia, Pennsylvania 19111 |
Gastroenterology Associates of Clinical Research | Kingsport, Tennessee 37660 |
Professional Quality Research, Inc. | Austin, Texas 78705 |
Gastroenterology Associates, PA | Houston, Texas 77034 |
Advanced Clinical Research of Houston | Houston, Texas 77062 |
Advanced Research Institute | Logan, Utah 84341 |
Salt Lake Research, PLLC | Salt Lake City, Utah 84107 |
Blue Ridge Medical Research | Lynchburg, Virginia 24502 |
Lakeview Medical Center | Suffolk, Virginia 23434 |
Marshfield Clinic-Eau Claire Center | Eau Claire, Wisconsin 54701 |
University of Wisconsin Milwaukee | Franklin, Wisconsin 53132 |
Marshfield Clinic-Weston Center | Weston, Wisconsin 54476 |
Cancer Coalition of South Georgia | Albany, Georgia 31707 |
Phoebe Digestive Health Center | Albany, Georgia 31707 |
Avicenna Clinical Research | Palos Heights, Illinois 60463 |
MGAGI Diagnostic and Therapeutic Center | Metairie, Louisiana 70006 |
Gastrointestinal Specialists | Taunton, Massachusetts 02780 |
Internal Medicine Associates | New York, New York 10029 |
Faculty Practice Associates | New York, New York 10029 |
GI Clinic | New York, New York 10029 |
Practice Associates | New York, New York 10029 |
UW Health West Clinic | Madison, Wisconsin 53717 |