Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01600209
First received: May 11, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.


Condition
Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

Resource links provided by NLM:


Further study details as provided by Exact Sciences Corporation:

Primary Outcome Measures:
  • Sensitivity and Specificity of the Exact CRC diagnostic screening test. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.


Biospecimen Retention:   Samples With DNA

Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.


Enrollment: 674
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings.

Detailed Description:

Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).

  Eligibility

Ages Eligible for Study:   50 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients are at average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.

Criteria

Inclusion Criteria:

  • Subject is male or female, 50-84 years of age, inclusive.
  • Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).
  • Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.
  • Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.

Exclusion Criteria:

  • Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
  • Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)
  • Subject has a history or recent diagnosis of CRC or adenoma.
  • Subject has a history of aerodigestive tract cancer.
  • Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
  • 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)
  • 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.
    • Greater than or equal to (>=)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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600209

Locations
United States, Arizona
Desert Sun Clinical Research
Tucson, Arizona, United States, 85710
United States, California
Remek Research
Pomona, California, United States, 91767
Sharp Rees-Stealy
San Diego, California, United States, 92101
Southern California Medical Gastroenterology Group, Inc
Santa Monica, California, United States, 90404
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
United States, Georgia
Atlanta Gastroenterology Associates
Marietta, Georgia, United States, 30067
United States, Illinois
Rockford Gastroenterology Associates, LTD.
Rockford, Illinois, United States, 61107
United States, Louisiana
New Orleans Research Institue
Metairie, Louisiana, United States, 70006
United States, Maryland
Columbia Medical Practice
Columbia, Maryland, United States, 21045
United States, Pennsylvania
Main Line Gastroenterology
Perkasie, Pennsylvania, United States, 18944
United States, Texas
Professional Quality Research, Inc.
Austin, Texas, United States, 78705
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
Advanced Research Institute
Sandy, Utah, United States, 84094
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
Study Chair: Graham Lidgard, PhD Chief Scientific Officer
  More Information

No publications provided

Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01600209     History of Changes
Other Study ID Numbers: Exact Sciences 2011-N
Study First Received: May 11, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Exact Sciences Corporation:
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

Additional relevant MeSH terms:
Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on August 27, 2014