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Colorectal NeoplasmsDeeP-CNCT01397747

Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

An observational study of Colorectal Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 184 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 84 yearsHealthy volunteers can take part
How many people
12,776 participants
Where
184 sitesin 2 countries
Study dates
Jun 2011to May 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients at average risk of developing colorectal cancer.

Who may be able to join

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

Who cannot join

  • Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
  • Subject has undergone colonoscopy within the previous nine (9) years.
  • Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
  • Subject has a history of colorectal cancer or adenoma.
  • Subject has a history of aerodigestive tract cancer.
  • Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
Show all 19Show fewer
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
  • 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).
  • 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.
  • 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").
  • 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.

Trial locations and contacts

184 sites in 2 countries.

184 sites in 2 countries

United States182 sites

  • Digestive Health Specialists, PA

    Advance, North Carolina, 27006

  • Cancer Coalition of South Georgia

    Albany, Georgia, 31707

  • Phoebe Digestive Health Center

    Albany, Georgia, 31707

  • HealthCare Partners

    Alhambra, California, 91801

  • HealthCare Partners

    Arcadia, California, 91006

  • Valley Gastro Consultants

    Arcadia, California, 91006

  • NCH Medical Group

    Arlington Heights, Illinois, 60004

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30318

  • Professional Quality Research, Inc.

    Austin, Texas, 78705

  • Professional Quality Research, Inc.

    Austin, Texas, 78745

  • Professional Quality Research, Inc.

    Austin, Texas, 78757

  • Main Line Gastroenterology

    Bala-Cynwyd, Pennsylvania, 19004

  • Digestive Disease Associates, PA

    Baltimore, Maryland, 21229

  • Gastrointestinal Diagnostic Center

    Baltimore, Maryland, 21229

  • Gastroenterology & Nutritional Medical Services

    Bastrop, Louisiana, 71220

  • Gastroenterology Associates

    Baton Rouge, Louisiana, 70809

  • Northwest Gastroenterology Associates

    Bellevue, Washington, 98004

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Desert Oasis Healthcare

    Bermuda Dunes, California, 92203

  • Binghamton Gastroenterology

    Binghamton, New York, 13903

  • Achieve Clinical Research

    Birmingham, Alabama, 35216

  • MediSpect

    Boone, North Carolina, 28607

  • Boston Medical Center: Center for Digestive Disorders

    Boston, Massachusetts, 02118

  • Boston Medical Center: Family Medicine

    Boston, Massachusetts, 02118

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Shapiro Ambulatory Care Center: Adult Primary Care

    Boston, Massachusetts, 02118

  • Shapiro Ambulatory Care Center: Women's Health Group

    Boston, Massachusetts, 02118

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Gastroenterology Associates

    Bristol, Tennessee, 37620

  • Commonwealth Clinical Studies PLLC

    Brockton, Massachusetts, 02302

  • NCH Medical Group

    Buffalo Grove, Illinois, 60089

  • HealthCare Partners

    Burbank, California, 91506

  • Carolina Digestive Health Associates

    Charlotte, North Carolina, 28262

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Metropolitan Gastroenterology Group

    Chevy Chase, Maryland, 20815

  • Jesse Brown VAMC

    Chicago, Illinois, 60612

  • Union Health Services

    Chicago, Illinois, 60612

  • Union Health Services

    Chicago, Illinois, 60652

  • REMEK Research

    Chino, California, 91710

  • Ohio GI & Liver Institute

    Cincinnati, Ohio, 45014

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Ohio GI & Liver Institute

    Cincinnati, Ohio, 45219

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Banks Hepatology Institute P.C.

    College Park, Maryland, 20740

  • Digestive Disease Associates

    Columbia, Maryland, 21044

  • Howard County GIDC

    Columbia, Maryland, 21044

  • Russell Schub

    Columbia, Maryland, 21044

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • Gasro Center of Maryland

    Columbia, Maryland, 21045

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Carolina Digestive Health Associates

    Concord, North Carolina, 28025

  • Carolina Digestive Health Associates

    Davidson, North Carolina, 28036

  • Southern California Oncology

    Downey, California, 90241

  • Commonwealth Clinical Studies PLLC

    East Bridgewater, Massachusetts, 02333

  • Marshfield Clinic-Eau Claire Center

    Eau Claire, Wisconsin, 54701

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • HealthCare Partners Medical Group

    El Monte, California, 91733

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Gastroenterology Associates

    Elkridge, Maryland, 21075

  • Regional Gastroenterology Associates of Lancaster

    Ephrata, Pennsylvania, 17522

  • Gastroenterology Associates of Fairfield County

    Fairfield, Connecticut, 06824

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • University of Wisconsin Milwaukee

    Franklin, Wisconsin, 53132

  • Southern California Oncology

    Fullerton, California, 92835

  • CBM Pathology

    Gaithersburg, Maryland, 20879

  • Gastro One

    Germantown, Tennessee, 38138

  • HealthCare Partners

    Glendale, California, 91204

  • HealthCare Partners

    Glendale, California, 91208

  • Valley Gastro Consultants

    Glendora, California, 91741

  • Gastrointestinal Research Group

    Great Neck, New York, 11023

  • Carolina Digestive Health Associates

    Harrisburg, North Carolina, 28075

  • Main Line Gastroenterology

    Havertown, Pennsylvania, 19083

  • VA Hospital

    Hines, Illinois, 60141

  • Atlanta Gastroenterology Associates

    Hiram, Georgia, 30141

  • Gastroenterology Associates, PA

    Houston, Texas, 77034

  • Advanced Clinical Research of Houston

    Houston, Texas, 77062

  • Houston Medical Research Associates

    Houston, Texas, 77090

  • HealthCare Partners

    Huntington Park, California, 90255

  • Roudebush VA Medical Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Digestive Health Specialists, PA

    Kernersville, North Carolina, 27284

  • Gastroenterology Associates of Clinical Research

    Kingsport, Tennessee, 37660

  • Regional Gastroenterology Associates of Lancaster

    Lancaster, Pennsylvania, 17604

  • Maryland Digestive Disease Center

    Laurel, Maryland, 20707

  • Advanced Research Institute

    Logan, Utah, 84341

  • Health Care Partners Medical Group

    Long Beach, California, 90806

  • Health Care Partners San Antonio

    Long Beach, California, 90807

  • VA Hospital

    Long Beach, California, 90822

  • Healthcare Partners Medical Group

    Los Angeles, California, 90015

  • HealthCare Partners

    Los Angeles, California, 90043

  • HealthCare Partners

    Los Angeles, California, 90063

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Southern California Oncology

    Lynwood, California, 90262

  • UW Health West Clinic

    Madison, Wisconsin, 53717

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

  • Main Line Gastroenterology

    Malvern, Pennsylvania, 19355

  • Atlanta Gastroenterology Associates

    Marietta, Georgia, 30060

  • Atlanta Gastroenterology Associates

    Marietta, Georgia, 30067

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Main Line Gastroenterology

    Media, Pennsylvania, 19063

  • Melbourne GI Center

    Melbourne, Florida, 32901

  • MIMA Century Research Associates

    Melbourne, Florida, 32901

  • MGAGI Diagnostic and Therapeutic Center

    Metairie, Louisiana, 70006

  • New Orleans Research Institute

    Metairie, Louisiana, 70006

  • Suncoast Research Group

    Miami, Florida, 33135

  • GI Care Center

    Miami, Florida, 33173

  • Gastro Health P.L.

    Miami, Florida, 33176

  • University of Wisconsin Milwaukee

    Milwaukee, Wisconsin, 53215

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Healthcare Partners- Mission Plaza

    Mission Hills, California, 91345

  • Healthcare Partners-Mission Hills

    Mission Hills, California, 91345

  • Delta Research Partners, LLC

    Monroe, Louisiana, 71201

  • REMEK Research

    Montclair, California, 91763

  • HealthCare Partners Medical Group

    Montebello, California, 90640

  • Monterey Bay GI Consultants Medical Group & Research Institute

    Monterey, California, 93940

  • Furtura Research

    Monterey Park, California, 91754

  • Healthcare Partners Medical Group

    Monterey Park, California, 91754

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Southwest Gastroenterology

    New Lenox, Illinois, 60451

  • Faculty Practice Associates

    New York, New York, 10029

  • GI Clinic

    New York, New York, 10029

  • Internal Medicine Associates

    New York, New York, 10029

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Practice Associates

    New York, New York, 10029

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Gastroenterology Associates of Tidewater

    Norfolk, Virginia, 23505

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Union Health Services

    Norridge, Illinois, 60706

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Diverse Research Solutions

    Oxnard, California, 93030

  • Desert Oasis Healthcare

    Palm Springs, California, 92262

  • Desert Regional Medical Center

    Palm Springs, California, 92262

  • Avicenna Clinical Research

    Palos Heights, Illinois, 60463

  • HealthCare Partners

    Pasadena, California, 91105

  • Gastroenterology Associates

    Pasadena, Maryland, 21122

  • Main Line Gastroenterology

    Perkasie, Pennsylvania, 18944

  • PGC Endoscopy Center Inc.

    Philadelphia, Pennsylvania, 19111

  • REMEK Research

    Pomona, California, 91767

  • Northwest Gastroenterology Clinic, LLC

    Portland, Oregon, 97210

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Health Care Partners

    Redondo Beach, California, 90277

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Rockford Gastroenterology Associates, LTD

    Rockford, Illinois, 61107

  • Professional Quality Research, Inc.

    Round Rock, Texas, 78681

  • Institute for Medical Research

    Sacramento, California, 95816

  • Salt Lake Research, PLLC

    Salt Lake City, Utah, 84107

  • Sharp-Rees-Stealy Medical Group

    San Diego, California, 92101

  • Sharp-Rees-Stealy Medical Group

    San Diego, California, 92123

  • Advanced Research Institute

    Sandy City, Utah, 84094

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Sansum Clinic

    Santa Barbara, California, 93110

  • Santa Monica Research Institute

    Santa Monica, California, 90404

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Louisiana Research Center

    Shreveport, Louisiana, 71103

  • Miami Research Associates

    South Miami, Florida, 33143

  • Lakeview Medical Center

    Suffolk, Virginia, 23434

  • Gastrointestinal Specialists

    Taunton, Massachusetts, 02780

  • Health Care Partners Medical Group

    Torrance, California, 90503

  • South Bay Gastroenterology Medical Group

    Torrance, California, 90505

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • Tujunga Medical Group

    Tujunga, California, 91042

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Healthcare Partners-Valencia

    Valencia, California, 91355

  • Healthcare Partners- Van Nuys

    Van Nuys, California, 91405

  • Gastroenterology Associates of Tidewater

    Virginia Beach, Virginia, 23462

  • Metropolitan Gastroenterology Group, PC

    Washington D.C., District of Columbia, 20006

  • Marshfield Clinic-Weston Center

    Weston, Wisconsin, 54476

  • Hanover Medical Specialists

    Wilmington, North Carolina, 28401

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Wilmington Gastroenterology Associates

    Wilmington, North Carolina, 28403

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • Atlanta Gastroenterology Associates

    Woodstock, Georgia, 30188

  • Main Line Gastroenterology

    Wynnewood, Pennsylvania, 19096

  • Southern California Oncology

    Yorba Linda, California, 92886

Other trials in United States

Canada2 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Alberta Health Services

    Calgary, Alberta, T2WIS7

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Keywords
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
Medical subject headings
Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01397747
Study groupRoleWhat they receive
Average risk patientsSubjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionFeb 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
12,776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397747
Sponsor's protocol ID
Exact Sciences 2011-01
Acronym
DeeP-C
Status last verified
Nov 2015
First submitted
18 Jul 2011
Last updated
3 Dec 2015
Data monitoring committee
No

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.

    PubMed 24645800

  • Garg SK, Hintz CF, Kolarik HJ, Mau B, Hubers J, Arce V, Ebner DW, Gurudu SR, Bi Y, Greenwood J, Kisiel JB, Chaudhary R. Longitudinal Data From a Large, Multitarget Stool DNA Colorectal Cancer Screening Program. Am J Gastroenterol. 2026 Sep 3. doi: 10.14309/ajg.0000000000004196. Online ahead of print.

    PubMed 42690929

  • Imperiale TF, Gagrat ZD, Krockenberger M, Porter K, Ziegler E, Leduc CM, Matter MB, Olson MC, Limburg PJ. Algorithm Development and Early Performance Evaluation of a Next-Generation Multitarget Stool DNA Screening Test for Colorectal Cancer. Gastro Hep Adv. 2024 May 17;3(6):740-748. doi: 10.1016/j.gastha.2024.05.002. eCollection 2024.

    PubMed 39280922

  • Ebner DW, Rushlow D, Mou J, Porter K, Finney Rutten LJ, Limburg P, Sancar F, Imperiale TF. Stool-Based Colorectal Cancer Screening Test Performance Characteristics in Those With and Without Hemorrhoids. Mayo Clin Proc Innov Qual Outcomes. 2023 Jul 19;7(4):320-326. doi: 10.1016/j.mayocpiqo.2023.06.003. eCollection 2023 Aug.

    PubMed 37502338

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 184 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer. (time frame: 90 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01397747, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.

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