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Spots Global Cancer Trial Database for Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

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Trial Identification

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

Interventions

Study Description

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.

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

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

Contact Details

Name: Thomas Imperiale, MD

Affiliation: Principal Study Investigator

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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