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



Status:Terminated
Conditions:Colorectal Cancer, Cancer, Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:40 - 90
Updated:4/17/2018
Start Date:October 2014
End Date:September 2017

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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.

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.

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.
We found this trial at
22
sites
Asheville, North Carolina 28801
Principal Investigator: Brian Garvin, MD
Phone: 828-350-3697
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Anderson, South Carolina 29621
Principal Investigator: James Kopp, MD
Phone: 846-261-9563
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Anderson, SC
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Brockton, Massachusetts 02302
Principal Investigator: Jerry Stern, MD
Phone: 505-588-9900
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Brockton, MA
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Calgary, Alberta
Principal Investigator: Robert Hilsden, MD
Phone: 403-592-5052
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Calgary,
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Chevy Chase, Maryland 20815
Principal Investigator: Robert Hardi, MD
Phone: 301-652-5520
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Chevy Chase, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Josh Melson, MD
Phone: 312-563-3892
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Columbia, Missouri 65201
Principal Investigator: Joseph Muscato, MD
Phone: 573-815-3833
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Columbia, MO
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Fayetteville, North Carolina 28304
Principal Investigator: Valli Kodali, MD
Phone: 910-484-8163
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Germantown, Tennessee 38138
Principal Investigator: Ziad Younes, MD
Phone: 901-507-1624
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Germantown, TN
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Hamden, Connecticut 06518
Principal Investigator: Paul Feuerstadt, MD
Phone: 203-281-5161
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Hamden, CT
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Holiday, Florida 34691
Principal Investigator: L. Michael Weiss, MD
Phone: 727-774-7093
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Holiday, FL
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Lynchburg, Virginia 24502
Principal Investigator: Larry Clark, MD
Phone: 434-455-8670
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Lynchburg, VA
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Malvern, Pennsylvania 19355
Principal Investigator: Anil Sharma, MD
Phone: 610-232-0442
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Malvern, PA
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Metairie, Louisiana 70006
Principal Investigator: George Catinis, MD
Phone: 504-456-8020
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Metairie, LA
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Metairie, Louisiana 70006
Principal Investigator: Jennifer Silinsky, MD
Phone: 504-456-8109
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Newport Beach, California 92663
Principal Investigator: John Homan, MD
Phone: 760-421-2993
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Norfolk, Virginia 23502
Principal Investigator: David Johnson, MD
Phone: 757-961-1133
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Norfolk, VA
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Principal Investigator: Charles A Ternent, MD
Phone: 402-934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Orlando, Florida 32803
Principal Investigator: William Ruderman, MD
Phone: 407-241-3289
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Orlando, FL
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Portland, Oregon 97210
Principal Investigator: William Bennetts, MD
Phone: 503-229-7181
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Portland, OR
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Saint Louis, Missouri 63141
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Shreveport, Louisiana 71103
Principal Investigator: Lawrence Johnson, MD
Phone: 318-213-3453
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