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

Colorectal Cancer Clinical Trial

— DeeP-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397747
• Other study ID #: Exact Sciences 2011-01
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: December 1, 2015
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2015
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12776
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 84 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colonic Diseases
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Diseases
• Gastrointestinal Diseases

Locations

Country	Name	City	State
Canada	Alberta Health Services	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
United States	Digestive Health Specialists, PA	Advance	North Carolina
United States	Cancer Coalition of South Georgia	Albany	Georgia
United States	Phoebe Digestive Health Center	Albany	Georgia
United States	HealthCare Partners	Alhambra	California
United States	HealthCare Partners	Arcadia	California
United States	Valley Gastro Consultants	Arcadia	California
United States	NCH Medical Group	Arlington Heights	Illinois
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
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	Main Line Gastroenterology	Bala Cynwyd	Pennsylvania
United States	Digestive Disease Associates, PA	Baltimore	Maryland
United States	Gastrointestinal Diagnostic Center	Baltimore	Maryland
United States	Gastroenterology & Nutritional Medical Services	Bastrop	Louisiana
United States	Gastroenterology Associates	Baton Rouge	Louisiana
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Desert Oasis Healthcare	Bermuda Dunes	California
United States	Binghamton Gastroenterology	Binghamton	New York
United States	Achieve Clinical Research	Birmingham	Alabama
United States	MediSpect	Boone	North Carolina
United States	Boston Medical Center	Boston	Massachusetts
United States	Boston Medical Center: Center for Digestive Disorders	Boston	Massachusetts
United States	Boston Medical Center: Family Medicine	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	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Gastroenterology Associates	Bristol	Tennessee
United States	Commonwealth Clinical Studies PLLC	Brockton	Massachusetts
United States	NCH Medical Group	Buffalo Grove	Illinois
United States	HealthCare Partners	Burbank	California
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Metropolitan Gastroenterology Group	Chevy Chase	Maryland
United States	Jesse Brown VAMC	Chicago	Illinois
United States	Union Health Services	Chicago	Illinois
United States	Union Health Services	Chicago	Illinois
United States	REMEK Research	Chino	California
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Ohio GI & Liver Institute	Cincinnati	Ohio
United States	Ohio GI & Liver Institute	Cincinnati	Ohio
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Banks Hepatology Institute P.C.	College Park	Maryland
United States	Columbia Medical Practice	Columbia	Maryland
United States	Digestive Disease Associates	Columbia	Maryland
United States	Gasro Center of Maryland	Columbia	Maryland
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Howard County GIDC	Columbia	Maryland
United States	Russell Schub	Columbia	Maryland
United States	Carolina Digestive Health Associates	Concord	North Carolina
United States	Carolina Digestive Health Associates	Davidson	North Carolina
United States	Southern California Oncology	Downey	California
United States	Commonwealth Clinical Studies PLLC	East Bridgewater	Massachusetts
United States	Marshfield Clinic-Eau Claire Center	Eau Claire	Wisconsin
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	HealthCare Partners Medical Group	El Monte	California
United States	Centennial Medical Group	Elkridge	Maryland
United States	Gastroenterology Associates	Elkridge	Maryland
United States	Regional Gastroenterology Associates of Lancaster	Ephrata	Pennsylvania
United States	Gastroenterology Associates of Fairfield County	Fairfield	Connecticut
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	University of Wisconsin Milwaukee	Franklin	Wisconsin
United States	Southern California Oncology	Fullerton	California
United States	CBM Pathology	Gaithersburg	Maryland
United States	Gastro One	Germantown	Tennessee
United States	HealthCare Partners	Glendale	California
United States	HealthCare Partners	Glendale	California
United States	Valley Gastro Consultants	Glendora	California
United States	Gastrointestinal Research Group	Great Neck	New York
United States	Carolina Digestive Health Associates	Harrisburg	North Carolina
United States	Main Line Gastroenterology	Havertown	Pennsylvania
United States	VA Hospital	Hines	Illinois
United States	Atlanta Gastroenterology Associates	Hiram	Georgia
United States	Advanced Clinical Research of Houston	Houston	Texas
United States	Gastroenterology Associates, PA	Houston	Texas
United States	Houston Medical Research Associates	Houston	Texas
United States	HealthCare Partners	Huntington Park	California
United States	Roudebush VA Medical Center	Indianapolis	Indiana
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Digestive Health Specialists, PA	Kernersville	North Carolina
United States	Gastroenterology Associates of Clinical Research	Kingsport	Tennessee
United States	Regional Gastroenterology Associates of Lancaster	Lancaster	Pennsylvania
United States	Maryland Digestive Disease Center	Laurel	Maryland
United States	Advanced Research Institute	Logan	Utah
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	Los Angeles	California
United States	HealthCare Partners	Los Angeles	California
United States	Healthcare Partners Medical Group	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Southern California Oncology	Lynwood	California
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	UW Health West Clinic	Madison	Wisconsin
United States	Main Line Gastroenterology	Malvern	Pennsylvania
United States	Atlanta Gastroenterology Associates	Marietta	Georgia
United States	Atlanta Gastroenterology Associates	Marietta	Georgia
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Main Line Gastroenterology	Media	Pennsylvania
United States	Melbourne GI Center	Melbourne	Florida
United States	MIMA Century Research Associates	Melbourne	Florida
United States	MGAGI Diagnostic and Therapeutic Center	Metairie	Louisiana
United States	New Orleans Research Institute	Metairie	Louisiana
United States	Gastro Health P.L.	Miami	Florida
United States	GI Care Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	University of Wisconsin Milwaukee	Milwaukee	Wisconsin
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
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	Delta Research Partners, LLC	Monroe	Louisiana
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	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Southwest Gastroenterology	New Lenox	Illinois
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	Mount Sinai School of Medicine	New York City	New York
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Gastroenterology Associates of Tidewater	Norfolk	Virginia
United States	Union Health Services	Norridge	Illinois
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Advanced Research Institute	Ogden	Utah
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	Avicenna Clinical Research	Palos Heights	Illinois
United States	Gastroenterology Associates	Pasadena	Maryland
United States	HealthCare Partners	Pasadena	California
United States	Main Line Gastroenterology	Perkasie	Pennsylvania
United States	PGC Endoscopy Center Inc.	Philadelphia	Pennsylvania
United States	REMEK Research	Pomona	California
United States	Northwest Gastroenterology Clinic, LLC	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Health Care Partners	Redondo Beach	California
United States	Advanced Research Institute	Reno	Nevada
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Rockford Gastroenterology Associates, LTD	Rockford	Illinois
United States	Professional Quality Research, Inc.	Round Rock	Texas
United States	Institute for Medical Research	Sacramento	California
United States	Salt Lake Research, PLLC	Salt Lake City	Utah
United States	Sharp-Rees-Stealy Medical Group	San Diego	California
United States	Sharp-Rees-Stealy Medical Group	San Diego	California
United States	Advanced Research Institute	Sandy	Utah
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	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Louisiana Research Center	Shreveport	Louisiana
United States	Miami Research Associates	South Miami	Florida
United States	Lakeview Medical Center	Suffolk	Virginia
United States	Gastrointestinal Specialists	Taunton	Massachusetts
United States	Health Care Partners Medical Group	Torrance	California
United States	South Bay Gastroenterology Medical Group	Torrance	California
United States	Center for Digestive Health	Troy	Michigan
United States	Desert Sun Clinical Research, LLC	Tucson	Arizona
United States	Tujunga Medical Group	Tujunga	California
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	Healthcare Partners-Valencia	Valencia	California
United States	Healthcare Partners- Van Nuys	Van Nuys	California
United States	Gastroenterology Associates of Tidewater	Virginia Beach	Virginia
United States	Metropolitan Gastroenterology Group, PC	Washington	District of Columbia
United States	Marshfield Clinic-Weston Center	Weston	Wisconsin
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	Atlanta Gastroenterology Associates	Woodstock	Georgia
United States	Main Line Gastroenterology	Wynnewood	Pennsylvania
United States	Southern California Oncology	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No