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Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing | Clinical Trials | Clareo Health

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

NCT01600209•Exact Sciences Corporation

View on ClinicalTrials.gov

Summary

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.

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

Age

50 - 84 years

Sex

ALL

Healthy Volunteers

Yes

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).
+4 more criteria

Locations (13)

Desert Sun Clinical Research

Tucson, Arizona, United States

Remek Research

Pomona, California, United States

Sharp Rees-Stealy

San Diego, California, United States

Southern California Medical Gastroenterology Group, Inc

Santa Monica, California, United States

Miami Research Associates

Miami, Florida, United States

Atlanta Gastroenterology Associates

Marietta, Georgia, United States

Rockford Gastroenterology Associates, LTD.

Rockford, Illinois, United States

New Orleans Research Institue

Metairie, Louisiana, United States

Columbia Medical Practice

Columbia, Maryland, United States

Main Line Gastroenterology

Perkasie, Pennsylvania, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

September 1, 2012

Last Updated

May 13, 2015

Enrollment

674

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.

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

Inclusion Criteria

Exclusion Criteria

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