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Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01397747
First received: July 18, 2011
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition
Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study

Resource links provided by NLM:


Further study details as provided by Exact Sciences Corporation:

Primary Outcome Measures:
  • Sensitivity and Specificity of the Exact CRC screening test with comparison to colonoscopy, both with respect to cancer. [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
    An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination.


Secondary Outcome Measures:
  • To compare the performance of the Exact CRC screening test to a commercially available FIT, both with respect to cancer and advanced adenoma. [ Time Frame: 14 Months ] [ Designated as safety issue: No ]
    Lesions will be confirmed as a malignant or precancerous by colonoscopy and histopathologic examination.


Biospecimen Retention:   Samples With DNA

Residual stool samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored in a commercial biorepository contracted by Exact Sciences or at Exact Sciences and may be used for future research.


Enrollment: 12776
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.

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

Ages Eligible for Study:   50 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients at average risk of developing colorectal cancer.

Criteria

Inclusion Criteria:

  1. Subject is average risk for development of colorectal cancer (as defined by the inclusion and exclusion criteria below).
  2. Subject is able and willing to undergo a screening colonoscopy within 90 days of enrollment.
  3. Subject is 50 to 84 years of age inclusive.
  4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
  5. Subject is able and willing to provide stool samples according to written instructions provided to them.

Exclusion Criteria:

  1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
  2. Subject has undergone colonoscopy within the previous nine (9) years.
  3. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
  4. Subject has a history of colorectal cancer or adenoma.
  5. Subject has a history of aerodigestive tract cancer.
  6. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
  8. Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding).
  9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

    • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
    • >= 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
    • One first-degree relative with CRC diagnosed before the age of 60.
    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
  10. Subject has a family history of:

    • Familial adenomatous polyposis (also referred to as "FAP").
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  11. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397747

  Hide Study Locations
Locations
United States, Alabama
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
United States, California
HealthCare Partners
Alhambra, California, United States, 91801
HealthCare Partners
Arcadia, California, United States, 91006
Valley Gastro Consultants
Arcadia, California, United States, 91006
Desert Oasis Healthcare
Bermuda Dunes, California, United States, 92203
HealthCare Partners
Burbank, California, United States, 91506
REMEK Research
Chino, California, United States, 91710
Southern California Oncology
Downey, California, United States, 90241
HealthCare Partners Medical Group
El Monte, California, United States, 91733
Southern California Oncology
Fullerton, California, United States, 92835
HealthCare Partners
Glendale, California, United States, 91204
HealthCare Partners
Glendale, California, United States, 91208
Valley Gastro Consultants
Glendora, California, United States, 91741
HealthCare Partners
Huntington Park, California, United States, 90255
Health Care Partners Medical Group
Long Beach, California, United States, 90806
Health Care Partners San Antonio
Long Beach, California, United States, 90807
VA Hospital
Long Beach, California, United States, 90822
HealthCare Partners
Los Angeles, California, United States, 90063
HealthCare Partners
Los Angeles, California, United States, 90043
Healthcare Partners Medical Group
Los Angeles, California, United States, 90015
Southern California Oncology
Lynwood, California, United States, 90262
Healthcare Partners-Mission Hills
Mission Hills, California, United States, 91345
Healthcare Partners- Mission Plaza
Mission Hills, California, United States, 91345
Facey Medical Foundation
Mission Hills, California, United States, 91345
REMEK Research
Montclair, California, United States, 91763
HealthCare Partners Medical Group
Montebello, California, United States, 90640
Monterey Bay GI Consultants Medical Group & Research Institute
Monterey, California, United States, 93940
Healthcare Partners Medical Group
Monterey Park, California, United States, 91754
Furtura Research
Monterey Park, California, United States, 91754
Diverse Research Solutions
Oxnard, California, United States, 93030
Desert Regional Medical Center
Palm Springs, California, United States, 92262
Desert Oasis Healthcare
Palm Springs, California, United States, 92262
HealthCare Partners
Pasadena, California, United States, 91105
REMEK Research
Pomona, California, United States, 91767
Health Care Partners
Redondo Beach, California, United States, 90277
Institute for Medical Research
Sacramento, California, United States, 95816
Sharp-Rees-Stealy Medical Group
San Diego, California, United States, 92101
Sharp-Rees-Stealy Medical Group
San Diego, California, United States, 92123
Sansum Clinic
Santa Barbara, California, United States, 93105
Sansum Clinic
Santa Barbara, California, United States, 93110
Santa Monica Research Institute
Santa Monica, California, United States, 90404
Health Care Partners Medical Group
Torrance, California, United States, 90503
South Bay Gastroenterology Medical Group
Torrance, California, United States, 90505
Tujunga Medical Group
Tujunga, California, United States, 91042
Healthcare Partners-Valencia
Valencia, California, United States, 91355
Healthcare Partners- Van Nuys
Van Nuys, California, United States, 91405
Southern California Oncology
Yorba Linda, California, United States, 92886
United States, Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States, 06606
Gastroenterology Associates of Fairfield County
Fairfield, Connecticut, United States, 06824
United States, District of Columbia
Metropolitan Gastroenterology Group, PC
Washington, District of Columbia, United States, 20006
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Melbourne GI Center
Melbourne, Florida, United States, 32901
MIMA Century Research Associates
Melbourne, Florida, United States, 32901
Gastro Health P.L.
Miami, Florida, United States, 33176
GI Care Center
Miami, Florida, United States, 33173
Suncoast Research Group
Miami, Florida, United States, 33135
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Georgia
Cancer Coalition of South Georgia
Albany, Georgia, United States, 31707
Phoebe Digestive Health Center
Albany, Georgia, United States, 31707
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30318
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
Atlanta Gastroenterology Associates
Hiram, Georgia, United States, 30141
Atlanta Gastroenterology Associates
Marietta, Georgia, United States, 30060
Atlanta Gastroenterology Associates
Marietta, Georgia, United States, 30067
Atlanta Gastroenterology Associates
Woodstock, Georgia, United States, 30188
United States, Illinois
NCH Medical Group
Arlington Heights, Illinois, United States, 60004
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
NCH Medical Group
Buffalo Grove, Illinois, United States, 60089
Union Health Services
Chicago, Illinois, United States, 60612
Union Health Services
Chicago, Illinois, United States, 60652
Jesse Brown VAMC
Chicago, Illinois, United States, 60612
VA Hospital
Hines, Illinois, United States, 60141
Southwest Gastroenterology
New Lenox, Illinois, United States, 60451
Union Health Services
Norridge, Illinois, United States, 60706
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
Avicenna Clinical Research
Palos Heights, Illinois, United States, 60463
Rockford Gastroenterology Associates, LTD
Rockford, Illinois, United States, 61107
United States, Indiana
Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States, 50325
United States, Louisiana
Gastroenterology & Nutritional Medical Services
Bastrop, Louisiana, United States, 71220
Gastroenterology Associates
Baton Rouge, Louisiana, United States, 70809
MGAGI Diagnostic and Therapeutic Center
Metairie, Louisiana, United States, 70006
New Orleans Research Institute
Metairie, Louisiana, United States, 70006
Delta Research Partners, LLC
Monroe, Louisiana, United States, 71201
Louisiana Research Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Digestive Disease Associates, PA
Baltimore, Maryland, United States, 21229
Gastrointestinal Diagnostic Center
Baltimore, Maryland, United States, 21229
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States, 20815
Banks Hepatology Institute P.C.
College Park, Maryland, United States, 20740
Gastro Center of Maryland
Columbia, Maryland, United States, 21045
Digestive Disease Associates
Columbia, Maryland, United States, 21044
Gasro Center of Maryland
Columbia, Maryland, United States, 21045
Columbia Medical Practice
Columbia, Maryland, United States, 21045
Howard County GIDC
Columbia, Maryland, United States, 21044
Russell Schub
Columbia, Maryland, United States, 21044
Centennial Medical Group
Elkridge, Maryland, United States, 21075
Gastroenterology Associates
Elkridge, Maryland, United States, 21075
CBM Pathology
Gaithersburg, Maryland, United States, 20879
Maryland Digestive Disease Center
Laurel, Maryland, United States, 20707
Gastroenterology Associates
Pasadena, Maryland, United States, 21122
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Boston Medical Center: Center for Digestive Disorders
Boston, Massachusetts, United States, 02118
Boston Medical Center: Family Medicine
Boston, Massachusetts, United States, 02118
Shapiro Ambulatory Care Center: Adult Primary Care
Boston, Massachusetts, United States, 02118
Shapiro Ambulatory Care Center: Women's Health Group
Boston, Massachusetts, United States, 02118
Commonwealth Clinical Studies PLLC
Brockton, Massachusetts, United States, 02302
Commonwealth Clinical Studies PLLC
East Bridgewater, Massachusetts, United States, 02333
Gastrointestinal Specialists
Taunton, Massachusetts, United States, 02780
United States, Michigan
Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Nevada
Advanced Research Institute
Reno, Nevada, United States, 89511
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Binghamton Gastroenterology
Binghamton, New York, United States, 13903
Gastrointestinal Research Group
Great Neck, New York, United States, 11023
Practice Associates
New York, New York, United States, 10029
Faculty Practice Associates
New York, New York, United States, 10029
GI Clinic
New York, New York, United States, 10029
Internal Medicine Associates
New York, New York, United States, 10029
Mount Sinai School of Medicine
New York, New York, United States, 10029
Mount Sinai School of Medicine
New York City, New York, United States, 10029
United States, North Carolina
Digestive Health Specialists, PA
Advance, North Carolina, United States, 27006
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
MediSpect
Boone, North Carolina, United States, 28607
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28262
Carolina Digestive Health Associates
Concord, North Carolina, United States, 28025
Carolina Digestive Health Associates
Davidson, North Carolina, United States, 28036
Cumberland Research Associates
Fayetteville, North Carolina, United States, 28304
Carolina Digestive Health Associates
Harrisburg, North Carolina, United States, 28075
Digestive Health Specialists, PA
Kernersville, North Carolina, United States, 27284
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Hanover Medical Specialists
Wilmington, North Carolina, United States, 28401
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
Ohio GI & Liver Institute
Cincinnati, Ohio, United States, 45014
Ohio GI & Liver Institute
Cincinnati, Ohio, United States, 45219
United States, Oregon
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, United States, 97210
United States, Pennsylvania
Main Line Gastroenterology
Bala Cynwyd, Pennsylvania, United States, 19004
Regional Gastroenterology Associates of Lancaster
Ephrata, Pennsylvania, United States, 17522
Main Line Gastroenterology
Havertown, Pennsylvania, United States, 19083
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604
Main Line Gastroenterology
Malvern, Pennsylvania, United States, 19355
Main Line Gastroenterology
Media, Pennsylvania, United States, 19063
Main Line Gastroenterology
Perkasie, Pennsylvania, United States, 18944
PGC Endoscopy Center Inc.
Philadelphia, Pennsylvania, United States, 19111
Main Line Gastroenterology
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Gastroenterology Associates
Bristol, Tennessee, United States, 37620
Gastro One
Germantown, Tennessee, United States, 38138
Gastroenterology Associates of Clinical Research
Kingsport, Tennessee, United States, 37660
United States, Texas
Professional Quality Research
Austin, Texas, United States, 78705
Professional Quality Research, Inc.
Austin, Texas, United States, 78705
Professional Quality Research, Inc.
Austin, Texas, United States, 78757
Professional Quality Research, Inc.
Austin, Texas, United States, 78745
Advanced Clinical Research of Houston
Houston, Texas, United States, 77062
Gastroenterology Associates, PA
Houston, Texas, United States, 77034
Houston Medical Research Associates
Houston, Texas, United States, 77090
Professional Quality Research, Inc.
Round Rock, Texas, United States, 78681
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Utah
Advanced Research Institute
Logan, Utah, United States, 84341
Advanced Research Institute
Ogden, Utah, United States, 84405
Salt Lake Research, PLLC
Salt Lake City, Utah, United States, 84107
Advanced Research Institute
Sandy, Utah, United States, 84094
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Gastroenterology Associates of Tidewater
Norfolk, Virginia, United States, 23505
Lakeview Medical Center
Suffolk, Virginia, United States, 23434
Gastroenterology Associates of Tidewater
Virginia Beach, Virginia, United States, 23462
United States, Washington
Northwest Gastroenterology Associates
Bellevue, Washington, United States, 98004
United States, Wisconsin
Marshfield Clinic-Eau Claire Center
Eau Claire, Wisconsin, United States, 54701
University of Wisconsin Milwaukee
Franklin, Wisconsin, United States, 53132
UW Health West Clinic
Madison, Wisconsin, United States, 53717
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
University of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States, 53215
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic-Weston Center
Weston, Wisconsin, United States, 54476
Canada, Alberta
Alberta Health Services
Calgary, Alberta, Canada, T2WIS7
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
Principal Investigator: Thomas Imperiale, MD Principal Study Investigator
  More Information

No publications provided by Exact Sciences Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01397747     History of Changes
Other Study ID Numbers: Exact Sciences 2011-01
Study First Received: July 18, 2011
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Exact Sciences Corporation:
Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:
Adenomatous Polyps
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms
Adenoma
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014