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

May 12, 2015 updated by: Exact Sciences Corporation
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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

674

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Desert Sun Clinical Research
    • California
      • Pomona, California, United States, 91767
        • REMEK Research
      • San Diego, California, United States, 92101
        • Sharp Rees-Stealy
      • Santa Monica, California, United States, 90404
        • Southern California Medical Gastroenterology Group, Inc
    • Florida
      • Miami, Florida, United States, 33173
        • Miami Research Associates
    • Georgia
      • Marietta, Georgia, United States, 30067
        • Atlanta Gastroenterology Associates
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates, Ltd.
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institue
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Columbia Medical Practice
    • Pennsylvania
      • Perkasie, Pennsylvania, United States, 18944
        • Main Line Gastroenterology
    • Texas
      • Austin, Texas, United States, 78705
        • Professional Quality Research, Inc.
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
      • Sandy, Utah, United States, 84094
        • Advanced Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
Time Frame: 10 months
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Sciences Corporation

Investigators

  • Study Chair: Graham Lidgard, PhD, Chief Scientific Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exact Sciences 2011-N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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