Clinical trial NCT01397747: Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Official title: Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer
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
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 12776
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at average risk of developing colorectal cancer.

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Clinical Research, LLC
state: Arizona
city: Alhambra
country: United States
facility: HealthCare Partners
state: California
city: Arcadia
country: United States
facility: HealthCare Partners
state: California
city: Arcadia
country: United States
facility: Valley Gastro Consultants
state: California
city: Bermuda Dunes
country: United States
facility: Desert Oasis Healthcare
state: California
city: Burbank
country: United States
facility: HealthCare Partners
state: California
city: Chino
country: United States
facility: REMEK Research
state: California
city: Downey
country: United States
facility: Southern California Oncology
state: California
city: El Monte
country: United States
facility: HealthCare Partners Medical Group
state: California
city: Fullerton
country: United States
facility: Southern California Oncology
state: California
city: Glendale
country: United States
facility: HealthCare Partners
state: California
city: Glendale
country: United States
facility: HealthCare Partners
state: California
city: Glendora
country: United States
facility: Valley Gastro Consultants
state: California
city: Huntington Park
country: United States
facility: HealthCare Partners
state: California
city: Long Beach
country: United States
facility: Health Care Partners Medical Group
state: California
city: Long Beach
country: United States
facility: Health Care Partners San Antonio
state: California
city: Long Beach
country: United States
facility: VA Hospital
state: California
city: Los Angeles
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Los Angeles
country: United States
facility: HealthCare Partners
state: California
city: Los Angeles
country: United States
facility: HealthCare Partners
state: California
city: Lynwood
country: United States
facility: Southern California Oncology
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Mission Hills
country: United States
facility: Healthcare Partners- Mission Plaza
state: California
city: Mission Hills
country: United States
facility: Healthcare Partners-Mission Hills
state: California
city: Montclair
country: United States
facility: REMEK Research
state: California
city: Montebello
country: United States
facility: HealthCare Partners Medical Group
state: California
city: Monterey Park
country: United States
facility: Furtura Research
state: California
city: Monterey Park
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Monterey
country: United States
facility: Monterey Bay GI Consultants Medical Group & Research Institute
state: California
city: Oxnard
country: United States
facility: Diverse Research Solutions
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Pasadena
country: United States
facility: HealthCare Partners
state: California
city: Pomona
country: United States
facility: REMEK Research
state: California
city: Redondo Beach
country: United States
facility: Health Care Partners
state: California
city: Sacramento
country: United States
facility: Institute for Medical Research
state: California
city: San Diego
country: United States
facility: Sharp-Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: Sharp-Rees-Stealy Medical Group
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Monica
country: United States
facility: Santa Monica Research Institute
state: California
city: Torrance
country: United States
facility: Health Care Partners Medical Group
state: California
city: Torrance
country: United States
facility: South Bay Gastroenterology Medical Group
state: California
city: Tujunga
country: United States
facility: Tujunga Medical Group
state: California
city: Valencia
country: United States
facility: Healthcare Partners-Valencia
state: California
city: Van Nuys
country: United States
facility: Healthcare Partners- Van Nuys
state: California
city: Yorba Linda
country: United States
facility: Southern California Oncology
state: California
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: Fairfield
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: Washington
country: United States
facility: Metropolitan Gastroenterology Group, PC
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Melbourne
country: United States
facility: Melbourne GI Center
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: GI Care Center
state: Florida
city: Miami
country: United States
facility: Gastro Health P.L.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Albany
country: United States
facility: Cancer Coalition of South Georgia
state: Georgia
city: Albany
country: United States
facility: Phoebe Digestive Health Center
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Hiram
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Woodstock
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Arlington Heights
country: United States
facility: NCH Medical Group
state: Illinois
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Buffalo Grove
country: United States
facility: NCH Medical Group
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VAMC
state: Illinois
city: Chicago
country: United States
facility: Union Health Services
state: Illinois
city: Chicago
country: United States
facility: Union Health Services
state: Illinois
city: Hines
country: United States
facility: VA Hospital
state: Illinois
city: New Lenox
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Norridge
country: United States
facility: Union Health Services
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Palos Heights
country: United States
facility: Avicenna Clinical Research
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, LTD
state: Illinois
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Bastrop
country: United States
facility: Gastroenterology & Nutritional Medical Services
state: Louisiana
city: Baton Rouge
country: United States
facility: Gastroenterology Associates
state: Louisiana
city: Metairie
country: United States
facility: MGAGI Diagnostic and Therapeutic Center
state: Louisiana
city: Metairie
country: United States
facility: New Orleans Research Institute
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: Baltimore
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Baltimore
country: United States
facility: Gastrointestinal Diagnostic Center
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: College Park
country: United States
facility: Banks Hepatology Institute P.C.
state: Maryland
city: Columbia
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Columbia
country: United States
facility: Howard County GIDC
state: Maryland
city: Columbia
country: United States
facility: Russell Schub
state: Maryland
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Columbia
country: United States
facility: Gasro Center of Maryland
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Elkridge
country: United States
facility: Gastroenterology Associates
state: Maryland
city: Gaithersburg
country: United States
facility: CBM Pathology
state: Maryland
city: Laurel
country: United States
facility: Maryland Digestive Disease Center
state: Maryland
city: Pasadena
country: United States
facility: Gastroenterology Associates
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center: Center for Digestive Disorders
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center: Family Medicine
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Shapiro Ambulatory Care Center: Adult Primary Care
state: Massachusetts
city: Boston
country: United States
facility: Shapiro Ambulatory Care Center: Women's Health Group
state: Massachusetts
city: Brockton
country: United States
facility: Commonwealth Clinical Studies PLLC
state: Massachusetts
city: East Bridgewater
country: United States
facility: Commonwealth Clinical Studies PLLC
state: Massachusetts
city: Taunton
country: United States
facility: Gastrointestinal Specialists
state: Massachusetts
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Reno
country: United States
facility: Advanced Research Institute
state: Nevada
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Binghamton
country: United States
facility: Binghamton Gastroenterology
state: New York
city: Great Neck
country: United States
facility: Gastrointestinal Research Group
state: New York
city: New York City
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Faculty Practice Associates
state: New York
city: New York
country: United States
facility: GI Clinic
state: New York
city: New York
country: United States
facility: Internal Medicine Associates
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Practice Associates
state: New York
city: Advance
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Boone
country: United States
facility: MediSpect
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Concord
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Davidson
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Harrisburg
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Kernersville
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Ohio GI & Liver Institute
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Ohio GI & Liver Institute
state: Ohio
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLC
state: Oregon
city: Bala Cynwyd
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Ephrata
country: United States
facility: Regional Gastroenterology Associates of Lancaster
state: Pennsylvania
city: Havertown
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster
state: Pennsylvania
city: Malvern
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Media
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Perkasie
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Philadelphia
country: United States
facility: PGC Endoscopy Center Inc.
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates of Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Austin
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Austin
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Houston
country: United States
facility: Gastroenterology Associates, PA
state: Texas
city: Houston
country: United States
facility: Advanced Clinical Research of Houston
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Round Rock
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Logan
country: United States
facility: Advanced Research Institute
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research, PLLC
state: Utah
city: Sandy
country: United States
facility: Advanced Research Institute
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Norfolk
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Suffolk
country: United States
facility: Lakeview Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Eau Claire
country: United States
facility: Marshfield Clinic-Eau Claire Center
state: Wisconsin
city: Franklin
country: United States
facility: University of Wisconsin Milwaukee
state: Wisconsin
city: Madison
country: United States
facility: UW Health West Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: University of Wisconsin Milwaukee
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Clinic-Minocqua Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Clinic-Weston Center
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
Study officials:
affiliation: Principal Study Investigator
name: Thomas Imperiale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.