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

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

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.

Study Overview

• Status: Completed
• Conditions: Digestive System Diseases; Colonic Diseases; Colorectal Neoplasms; 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.

• Study Type: Observational
• Enrollment (Actual): 12776

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at average risk of developing colorectal cancer.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Average risk patients; Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy).	90 Days

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Investigators: Principal Investigator: Thomas Imperiale, MD, Principal Study Investigator

Publications and helpful links

General Publications

• Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colorectal Cancer; Colonic Diseases; Neoplasm; Neoplasms by Site; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Rectal Diseases; Colorectal Neoplasm
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Adenoma; Neoplasms; Colorectal Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Adenomatous Polyps
• Other Study ID Numbers: Exact Sciences 2011-01