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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 ScottsdaleScottsdale, Arizona  85259
Mount Sinai School of MedicineNew York, New York  10029
Marshfield ClinicMarshfield, Wisconsin  54449
Northwest Community HospitalArlington Heights, Illinois  60005
Boston Medical CenterBoston, Massachusetts  02118
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Gastroenterology Associates of Fairfield CountyBridgeport, Connecticut  06606
Asheville Gastroenterology AssociatesAsheville, North Carolina  28801
Regional Gastroenterology Associates of LancasterLancaster, Pennsylvania  17604
Northwest Gastroenterology AssociatesBellevue, Washington  98004
Atlanta Gastroenterology AssociatesAtlanta, Georgia  
Professional Quality ResearchAustin, Texas  78756
Facey Medical FoundationMission Hills, California  91345
Desert Regional Medical CenterPalm Springs, California  92262
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Mayo Clinic RochesterRochester, Minnesota  55905
Healthcare Partners Medical GroupTorrance, California  90503
Hanover Medical SpecialistsWilmington, North Carolina  28401
Wake Research AssociatesRaleigh, North Carolina  27612
Digestive Disease AssociatesBaltimore, Maryland  21229
Roudebush VA Medical CenterIndianapolis, Indiana  
Summit Medical GroupSummit, New Jersey  07901
Miami Research AssociatesMiami, Florida  33173
University of Wisconsin MadisonMadison, Wisconsin  53792
Mayo Clinic FloridaJacksonville, Florida  32224
Aga Clinical Research Associates, LlcEgg Harbor Twp, New Jersey  08234
Consultants For Clinical ResearchCincinnati, Ohio  45219
Clinical Research Associates of TidewaterNorfolk, Virginia  23507
Gastroenterology AssociatesKingsport, Tennessee  37660
Gastroenterology Associates of TidewaterChesapeake, Virginia  23320
Wilmington Gastroenterology AssociatesWilmington, North Carolina  28403
Centennial Medical GroupElkridge, Maryland  21075
Sansum ClinicSanta Barbara, California  93105
Columbia Medical PracticeColumbia, Maryland  21045
Houston Medical Research AssociatesHouston, Texas  77090
Charlottesville Medical ResearchCharlottesville, Virginia  22911
Carolina Digestive Health AssociatesHarrisburg, North Carolina  28075
Iowa Digestive Disease CenterClive, Iowa  50325
Gastroenterology AssociatesBaton Rouge, Louisiana  70809
Center for Digestive HealthTroy, Michigan  48098
Digestive Health Specialists of TylerTyler, Texas  75701
GI Care CenterMiami, Florida  33173
Digestive Health Specialists, PAWinston Salem, North Carolina  27103
Jesse Brown VAMCChicago, Illinois  60612
Achieve Clinical ResearchBirmingham, Alabama  35209
Rockford Gastroenterology Associates, LtdRockford, Illinois  61107
Northwest Gastroenterology Clinic, LLCPortland, Oregon  97208
Gastro OneGermantown, Tennessee  38138
Digestive and Liver Disease SpecialistsNorfolk, Virginia  23502
VA HospitalLos Angeles, California  90073
Coastal Carolina Research CenterMt. Pleasant, South Carolina  29464
Desert Sun Clinical Research, LLCTucson, Arizona  85710
HealthCare PartnersAlhambra, California  91801
Valley Gastro ConsultantsArcadia, California  91006
Desert Oasis HealthcareBermuda Dunes, California  92203
Southern California OncologyDowney, California  90241
Health Care Partners Medical GroupLong Beach, California  90806
Health Care Partners San AntonioLong Beach, California  90807
Healthcare Partners-Mission HillsMission Hills, California  91345
Healthcare Partners- Mission PlazaMission Hills, California  91345
Monterey Bay GI Consultants Medical Group & Research InstituteMonterey, California  93940
Furtura ResearchMonterey Park, California  91754
Diverse Research SolutionsOxnard, California  93030
REMEK ResearchPomona, California  91767
Health Care PartnersRedondo Beach, California  90277
Institute for Medical ResearchSacramento, California  95816
Sharp-Rees-Stealy Medical GroupSan Diego, California  92101
Santa Monica Research InstituteSanta Monica, California  90404
South Bay Gastroenterology Medical GroupTorrance, California  90505
Tujunga Medical GroupTujunga, California  91042
Healthcare Partners-ValenciaValencia, California  91355
Healthcare Partners- Van NuysVan Nuys, California  91405
Metropolitan Gastroenterology Group, PCWashington, District of Columbia  20006
MIMA Century Research AssociatesMelbourne, Florida  32901
Melbourne GI CenterMelbourne, Florida  32901
Suncoast Research GroupMiami, Florida  33135
Gastro Health P.L.Miami, Florida  33176
NCH Medical GroupArlington Heights, Illinois  60004
Union Health ServicesChicago, Illinois  60652
VA HospitalHines, Illinois  60141
Southwest GastroenterologyNew Lenox, Illinois  60451
Gastroenterology & Nutritional Medical ServicesBastrop, Louisiana  71220
New Orleans Research InstituteMetairie, Louisiana  70006
Delta Research Partners, LLCMonroe, Louisiana  71201
Louisiana Research CenterShreveport, Louisiana  71103
Digestive Disease Associates, PABaltimore, Maryland  21229
Gastrointestinal Diagnostic CenterBaltimore, Maryland  21229
Metropolitan Gastroenterology GroupChevy Chase, Maryland  20815
Banks Hepatology Institute P.C.College Park, Maryland  20740
Howard County GIDCColumbia, Maryland  21044
Russell SchubColumbia, Maryland  21044
Gasro Center of MarylandColumbia, Maryland  21045
Gastro Center of MarylandColumbia, Maryland  21045
Gastroenterology AssociatesElkridge, Maryland  21075
CBM PathologyGaithersburg, Maryland  20879
Maryland Digestive Disease CenterLaurel, Maryland  20707
Shapiro Ambulatory Care Center: Women's Health GroupBoston, Massachusetts  02118
Shapiro Ambulatory Care Center: Adult Primary CareBoston, Massachusetts  02118
Boston Medical Center: Family MedicineBoston, Massachusetts  02118
Boston Medical Center: Center for Digestive DisordersBoston, Massachusetts  02118
Commonwealth Clinical Studies PLLCBrockton, Massachusetts  02302
Advanced Research InstituteReno, Nevada  89511
Binghamton GastroenterologyBinghamton, New York  13903
Gastrointestinal Research GroupGreat Neck, New York  11023
MediSpectBoone, North Carolina  28607
Cumberland Research AssociatesFayetteville, North Carolina  28304
Ohio GI & Liver InstituteCincinnati, Ohio  45219
Main Line GastroenterologyBala Cynwyd, Pennsylvania  19004
PGC Endoscopy Center Inc.Philadelphia, Pennsylvania  19111
Gastroenterology Associates of Clinical ResearchKingsport, Tennessee  37660
Professional Quality Research, Inc.Austin, Texas  78705
Gastroenterology Associates, PAHouston, Texas  77034
Advanced Clinical Research of HoustonHouston, Texas  77062
Advanced Research InstituteLogan, Utah  84341
Salt Lake Research, PLLCSalt Lake City, Utah  84107
Blue Ridge Medical ResearchLynchburg, Virginia  24502
Lakeview Medical CenterSuffolk, Virginia  23434
Marshfield Clinic-Eau Claire CenterEau Claire, Wisconsin  54701
University of Wisconsin MilwaukeeFranklin, Wisconsin  53132
Marshfield Clinic-Weston CenterWeston, Wisconsin  54476
Cancer Coalition of South GeorgiaAlbany, Georgia  31707
Phoebe Digestive Health CenterAlbany, Georgia  31707
Avicenna Clinical ResearchPalos Heights, Illinois  60463
MGAGI Diagnostic and Therapeutic CenterMetairie, Louisiana  70006
Gastrointestinal SpecialistsTaunton, Massachusetts  02780
Internal Medicine AssociatesNew York, New York  10029
Faculty Practice AssociatesNew York, New York  10029
GI ClinicNew York, New York  10029
Practice AssociatesNew York, New York  10029
UW Health West ClinicMadison, Wisconsin  53717