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

Exact Sciences Corporation22 sites in 2 countries397 target enrollmentOctober 2014

ConditionsColorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Neoplasms
Sponsor: Exact Sciences Corporation
Enrollment: 397
Locations: 22
Primary Endpoint: To provide stool and blood specimens to assess new markers for the detection of CRC
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

September 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Exact Sciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

To provide stool and blood specimens to assess new markers for the detection of CRC

Time Frame: 33 months

Secondary Outcomes

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.)(33 months)
To provide quality control material for use in assessing performance of developed assays(33 months)
To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development(33 months)