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Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies


N/A
40 Years
90 Years
Open (Enrolling)
Both
Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

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Trial Information

Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies


Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be
asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the
option of submitting blood and tissue samples for future colo-rectal cancer-related test
development.


Inclusion Criteria:



1. Subject is male or female, 40-90 years of age, inclusive.

2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or
≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient
size to require surgical excision or complex colonoscopic polypectomy.

3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

1. Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung,
esophagus, stomach, or pancreatic cancer).

2. Subject has a history of any inflammatory bowel disease.

3. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal
cancer (Lynch) syndrome, or other hereditary cancer syndromes.

4. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only

Outcome Measure:

The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.

Outcome Description:

The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.

Outcome Time Frame:

12 Months

Safety Issue:

No

Principal Investigator

Graham Lidgard, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chief Scientific Officer

Authority:

United States: Institutional Review Board

Study ID:

Exact Sciences 2010-A

NCT ID:

NCT01260168

Start Date:

October 2010

Completion Date:

August 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

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
University of Illinois at ChicagoChicago, Illinois  60612
University of UtahSalt Lake City, Utah  
Chevy Chase Clinical ResearchChevy Chase, Maryland  
Achieve Clinical Research, LLCTuscaloosa, Alabama  35406
Gastroenterology AssociatesBaton Rouge, Louisiana  70809
Southern Gastroenterology AssociatesNew Bern, North Carolina  28562
Clinical Research AssociatesHuntsville, Alabama  35801
Atlanta GastroenterologyAtlanta, Georgia  30308
Stroger Cook CountyChicago, Illinois  60612
Rush University GastroenterologistsChicago, Illinois  60612
Jesse Brown VAChicago, Illinois  60612
Rockford Gastroenterology Associates, LtdRockford, Illinois  61107
Commonwealth Clinical StudiesBrockton, Massachusetts  02302
Long Island Gastrointestinal GroupGreat Neck, New York  11023
Asheville GastroenterologyAsheville, North Carolina  28801
Northwest Gastroenterology Clinic, LLCPortland, Oregon  97208
Gastro OneGermantown, Tennessee  38138
Digestive Health SpecialistsTyler, Texas  75701
Digestive and Liver Disease SpecialistsNorfolk, Virginia  23502