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



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:40 - 90
Updated:11/23/2013
Start Date:October 2010
End Date:August 2013
Contact:Nada Mlinarevich, MPH, RN
Email:nmlinarevich@exactsciences.com
Phone:(608) 284-5747

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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.


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.

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.
We found this trial at
20
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Germantown, Tennessee 38138
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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3100 Wellons Blvd.
New Bern, North Carolina 28562
252-634-9000
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1 Gustave L Levy Pl # 504
New York, New York 10029
 (212) 241-6500
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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401 Roxbury Road
Rockford, Illinois 61107
815-397-7340
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Asheville, North Carolina 28801
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Atlanta, Georgia 30308
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Baton Rouge, Louisiana 70809
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Brockton, Massachusetts 02302
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Chevy Chase, Maryland 20815
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Chicago, Illinois 60612
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Chicago, Illinois 60612
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Chicago, Illinois 60612
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Great Neck, New York 11023
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Huntsville, Alabama 35801
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Norfolk, Virginia 23502
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Tyler, Texas 75701
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