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Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies | Clinical Trials | Clareo Health

COMPLETED

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

NCT01260168•Exact Sciences Corporation

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

40 - 90 years

Sex

ALL

Healthy Volunteers

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.

Locations (21)

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

Clinical Research Associates

Huntsville, Alabama, United States

Atlanta Gastroenterology

Atlanta, Georgia, United States

Jesse Brown VA

Chicago, Illinois, United States

Rush University Gastroenterologists

Chicago, Illinois, United States

Stroger Cook County

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Rockford Gastroenterology Associates, Ltd

Rockford, Illinois, United States

Gastroenterology Associates

Baton Rouge, Louisiana, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

November 1, 2013

Completion Date

November 1, 2013

Last Updated

May 13, 2015

Enrollment

435

ACTUAL participants

Conditions

Colorectal NeoplasmsDigestive System DiseasesColonic DiseasesColorectal Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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