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

NCT ID: NCT01397747

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12776 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Average risk patients

Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Exact Sciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Imperiale, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Study Investigator

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

Monterey Bay GI Consultants Medical Group & Research Institute

Monterey, California, United States

Furtura Research

Monterey Park, California, United States

Healthcare Partners Medical Group

Monterey Park, 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 D.C., 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, New Jersey, United States

Binghamton Gastroenterology

Binghamton, New York, United States

Gastrointestinal Research Group

Great Neck, 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 City, 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

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 24645800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39280922 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37502338 (View on PubMed)

Other Identifiers

Exact Sciences 2011-01

Identifier Type: -

Identifier Source: org_study_id