Colon Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Estimated Enrollment:

397

Study ID:

NCT02503631

Recruitment Status:

Terminated

Sponsor:

Exact Sciences Corporation

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There are 22 Locations for this study

See Locations Near You

John D. Homan, MD
Newport Beach California, 92663, United States
Medical Research Center of Connecticut
Hamden Connecticut, 06518, United States
Gulf Coast Research Group, LLC
Holiday Florida, 34691, United States
Endoscopic Research, Inc.
Orlando Florida, 32803, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Colon and Rectal Surgery Associates
Metairie Louisiana, 70001, United States
New Orleans Research Institute
Metairie Louisiana, 70006, United States
Louisiana Research Center, LLC
Shreveport Louisiana, 71103, United States
Chevy Chase Clinical Research
Chevy Chase Maryland, 20815, United States
Commonwealth Clinical Studies
Brockton Massachusetts, 02302, United States
DBA Boone Hospital Center
Columbia Missouri, 65201, United States
Sundance Clinical Research, LLC
Saint Louis Missouri, 63141, United States
Quality Clinical Research, Inc.
Omaha Nebraska, 68114, United States
Asheville Gastroenterology Associates, PA
Asheville North Carolina, 28801, United States
Cumberland Research Associates, LLC
Fayetteville North Carolina, 28304, United States
Northwest Gastroenterology Clinic, LLC
Portland Oregon, 97210, United States
Main Line Gastroenterology Associates
Malvern Pennsylvania, 19355, United States
Radiant Research, Inc.
Anderson South Carolina, 29621, United States
Gastro One
Germantown Tennessee, 38138, United States
Blue Ridge Medical Researcj
Lynchburg Virginia, 24502, United States
Digestive and Liver Disease Specialists
Norfolk Virginia, 23502, United States
Forzani & MacPhali Colon Cancer Screening Centre
Calgary Alberta, T2N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

397

Study ID:

NCT02503631

Recruitment Status:

Terminated

Sponsor:


Exact Sciences Corporation

How clear is this clinincal trial information?

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