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

May 12, 2015 updated by: Exact Sciences Corporation

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

Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

435

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA
      • Chicago, Illinois, United States, 60612
        • Rush University Gastroenterologists
      • Chicago, Illinois, United States, 60612
        • Stroger Cook County
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates, Ltd
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Commonwealth Clinical Studies
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Group
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology
      • New Bern, North Carolina, United States, 28562
        • Southern Gastroenterology Associates
    • Oregon
      • Portland, Oregon, United States, 97208
        • Northwest Gastroenterology Clinic, LLC
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
    • Texas
      • Tyler, Texas, United States, 75701
        • Digestive Health Specialists
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists

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

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Colorectal cancer patients
Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
Time Frame: 12 Months
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To collect samples from patients diagnosed with colorectal cancers.
Time Frame: 12 Months
Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.
12 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, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 15, 2010

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 2010-A

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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