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


N/A
50 Years
84 Years
Not Enrolling
Both
Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Sensitivity and Specificity of the Exact CRC screening test with comparison to colonoscopy, both with respect to cancer.

Outcome Description:

An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination.

Outcome Time Frame:

14 Months

Safety Issue:

No

Principal Investigator

Thomas Imperiale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Principal Study Investigator

Authority:

United States: Food and Drug Administration

Study ID:

Exact Sciences 2011-01

NCT ID:

NCT01397747

Start Date:

June 2011

Completion Date:

May 2013

Related Keywords:

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

Name

Location

Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mount Sinai School of Medicine New York, New York  10029
Marshfield Clinic Marshfield, Wisconsin  54449
Northwest Community Hospital Arlington Heights, Illinois  60005
Boston Medical Center Boston, Massachusetts  02118
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Gastroenterology Associates of Fairfield County Bridgeport, Connecticut  06606
Asheville Gastroenterology Associates Asheville, North Carolina  28801
Regional Gastroenterology Associates of Lancaster Lancaster, Pennsylvania  17604
Northwest Gastroenterology Associates Bellevue, Washington  98004
Atlanta Gastroenterology Associates Atlanta, Georgia  
Professional Quality Research Austin, Texas  78756
Facey Medical Foundation Mission Hills, California  91345
Desert Regional Medical Center Palm Springs, California  92262
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
Mayo Clinic Rochester Rochester, Minnesota  55905
Healthcare Partners Medical Group Torrance, California  90503
Hanover Medical Specialists Wilmington, North Carolina  28401
Wake Research Associates Raleigh, North Carolina  27612
Digestive Disease Associates Baltimore, Maryland  21229
Roudebush VA Medical Center Indianapolis, Indiana  
Summit Medical Group Summit, New Jersey  07901
Miami Research Associates Miami, Florida  33173
University of Wisconsin Madison Madison, Wisconsin  53792
Mayo Clinic Florida Jacksonville, Florida  32224
Aga Clinical Research Associates, Llc Egg Harbor Twp, New Jersey  08234
Consultants For Clinical Research Cincinnati, Ohio  45219
Clinical Research Associates of Tidewater Norfolk, Virginia  23507
Gastroenterology Associates Kingsport, Tennessee  37660
Gastroenterology Associates of Tidewater Chesapeake, Virginia  23320
Wilmington Gastroenterology Associates Wilmington, North Carolina  28403
Centennial Medical Group Elkridge, Maryland  21075
Sansum Clinic Santa Barbara, California  93105
Columbia Medical Practice Columbia, Maryland  21045
Houston Medical Research Associates Houston, Texas  77090
Charlottesville Medical Research Charlottesville, Virginia  22911
Carolina Digestive Health Associates Harrisburg, North Carolina  28075
Iowa Digestive Disease Center Clive, Iowa  50325
Gastroenterology Associates Baton Rouge, Louisiana  70809
Center for Digestive Health Troy, Michigan  48098
Digestive Health Specialists of Tyler Tyler, Texas  75701
GI Care Center Miami, Florida  33173
Digestive Health Specialists, PA Winston Salem, North Carolina  27103
Jesse Brown VAMC Chicago, Illinois  60612
Achieve Clinical Research Birmingham, Alabama  35209
Rockford Gastroenterology Associates, Ltd Rockford, Illinois  61107
Northwest Gastroenterology Clinic, LLC Portland, Oregon  97208
Gastro One Germantown, Tennessee  38138
Digestive and Liver Disease Specialists Norfolk, Virginia  23502
VA Hospital Los Angeles, California  90073
Coastal Carolina Research Center Mt. Pleasant, South Carolina  29464
Desert Sun Clinical Research, LLC Tucson, Arizona  85710
HealthCare Partners Alhambra, California  91801
Valley Gastro Consultants Arcadia, California  91006
Desert Oasis Healthcare Bermuda Dunes, California  92203
Southern California Oncology Downey, California  90241
Health Care Partners Medical Group Long Beach, California  90806
Health Care Partners San Antonio Long Beach, California  90807
Healthcare Partners-Mission Hills Mission Hills, California  91345
Healthcare Partners- Mission Plaza Mission Hills, California  91345
Monterey Bay GI Consultants Medical Group & Research Institute Monterey, California  93940
Furtura Research Monterey Park, California  91754
Diverse Research Solutions Oxnard, California  93030
REMEK Research Pomona, California  91767
Health Care Partners Redondo Beach, California  90277
Institute for Medical Research Sacramento, California  95816
Sharp-Rees-Stealy Medical Group San Diego, California  92101
Santa Monica Research Institute Santa Monica, California  90404
South Bay Gastroenterology Medical Group Torrance, California  90505
Tujunga Medical Group Tujunga, California  91042
Healthcare Partners-Valencia Valencia, California  91355
Healthcare Partners- Van Nuys Van Nuys, California  91405
Metropolitan Gastroenterology Group, PC Washington, District of Columbia  20006
MIMA Century Research Associates Melbourne, Florida  32901
Melbourne GI Center Melbourne, Florida  32901
Suncoast Research Group Miami, Florida  33135
Gastro Health P.L. Miami, Florida  33176
NCH Medical Group Arlington Heights, Illinois  60004
Union Health Services Chicago, Illinois  60652
VA Hospital Hines, Illinois  60141
Southwest Gastroenterology New Lenox, Illinois  60451
Gastroenterology & Nutritional Medical Services Bastrop, Louisiana  71220
New Orleans Research Institute Metairie, Louisiana  70006
Delta Research Partners, LLC Monroe, Louisiana  71201
Louisiana Research Center Shreveport, Louisiana  71103
Digestive Disease Associates, PA Baltimore, Maryland  21229
Gastrointestinal Diagnostic Center Baltimore, Maryland  21229
Metropolitan Gastroenterology Group Chevy Chase, Maryland  20815
Banks Hepatology Institute P.C. College Park, Maryland  20740
Howard County GIDC Columbia, Maryland  21044
Russell Schub Columbia, Maryland  21044
Gasro Center of Maryland Columbia, Maryland  21045
Gastro Center of Maryland Columbia, Maryland  21045
Gastroenterology Associates Elkridge, Maryland  21075
CBM Pathology Gaithersburg, Maryland  20879
Maryland Digestive Disease Center Laurel, Maryland  20707
Shapiro Ambulatory Care Center: Women's Health Group Boston, Massachusetts  02118
Shapiro Ambulatory Care Center: Adult Primary Care Boston, Massachusetts  02118
Boston Medical Center: Family Medicine Boston, Massachusetts  02118
Boston Medical Center: Center for Digestive Disorders Boston, Massachusetts  02118
Commonwealth Clinical Studies PLLC Brockton, Massachusetts  02302
Advanced Research Institute Reno, Nevada  89511
Binghamton Gastroenterology Binghamton, New York  13903
Gastrointestinal Research Group Great Neck, New York  11023
MediSpect Boone, North Carolina  28607
Cumberland Research Associates Fayetteville, North Carolina  28304
Ohio GI & Liver Institute Cincinnati, Ohio  45219
Main Line Gastroenterology Bala Cynwyd, Pennsylvania  19004
PGC Endoscopy Center Inc. Philadelphia, Pennsylvania  19111
Gastroenterology Associates of Clinical Research Kingsport, Tennessee  37660
Professional Quality Research, Inc. Austin, Texas  78705
Gastroenterology Associates, PA Houston, Texas  77034
Advanced Clinical Research of Houston Houston, Texas  77062
Advanced Research Institute Logan, Utah  84341
Salt Lake Research, PLLC Salt Lake City, Utah  84107
Blue Ridge Medical Research Lynchburg, Virginia  24502
Lakeview Medical Center Suffolk, Virginia  23434
Marshfield Clinic-Eau Claire Center Eau Claire, Wisconsin  54701
University of Wisconsin Milwaukee Franklin, Wisconsin  53132
Marshfield Clinic-Weston Center Weston, Wisconsin  54476
Cancer Coalition of South Georgia Albany, Georgia  31707
Phoebe Digestive Health Center Albany, Georgia  31707
Avicenna Clinical Research Palos Heights, Illinois  60463
MGAGI Diagnostic and Therapeutic Center Metairie, Louisiana  70006
Gastrointestinal Specialists Taunton, Massachusetts  02780
Internal Medicine Associates New York, New York  10029
Faculty Practice Associates New York, New York  10029
GI Clinic New York, New York  10029
Practice Associates New York, New York  10029
UW Health West Clinic Madison, Wisconsin  53717