Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

April 4, 2018 updated by: Exact Sciences Corporation
The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

Study Type

Observational

Enrollment (Actual)

397

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
        • Forzani & MacPhali Colon Cancer Screening Centre
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • John D. Homan, MD
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut
    • Florida
      • Holiday, Florida, United States, 34691
        • Gulf Coast Research Group, LLC
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute
      • Metairie, Louisiana, United States, 70001
        • Colon and Rectal Surgery Associates
      • Shreveport, Louisiana, United States, 71103
        • Louisiana Research Center, LLC
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Commonwealth Clinical Studies
    • Missouri
      • Columbia, Missouri, United States, 65201
        • DBA Boone Hospital Center
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, PA
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic, LLC
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Main Line Gastroenterology Associates
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research, Inc.
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Researcj
      • 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

Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

Description

Inclusion Criteria:

  • Subject is male or female, 40-90 years of age, inclusive.
  • Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
  • Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
  • 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
Intervention / Treatment
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 a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
Device: Stool Sample Collection Kit
Stool sample collection kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide stool and blood specimens to assess new markers for the detection of CRC
Time Frame: 33 months
33 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.)
Time Frame: 33 months
33 months
To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development
Time Frame: 33 months
33 months
To provide quality control material for use in assessing performance of developed assays
Time Frame: 33 months
33 months

Collaborators and Investigators

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

Sponsor

Exact Sciences Corporation

Investigators

  • Study Chair: Michael Domanico, Exact Sciences

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 (Actual)

October 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-02

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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