Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:3/30/2019
Start Date:January 3, 2019
End Date:March 2020
Contact:Alexandra Massoud
Email:amassoud@exactsciences.com
Phone:608-957-5652

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The primary objective of this study is to collect de-identified, clinically-characterized
stool and whole blood specimens for use in developing and evaluating the performance of new
biomarker assays for detection of colorectal cancer (CRC).

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy.
Approximately 3,000 subjects will be enrolled.

Inclusion Criteria:

- Subject is male or female, 40 years of age or older.

- Subject is at average or increased risk for development of CRC.

- Subject presents for screening or surveillance colonoscopy.

- Subject has no symptoms that require immediate, or near term, referral for diagnostic
or therapeutic colonoscopy.

- 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:

- Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin
cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation,
and/or surgery) within the past 5 years.

- Subject has a diagnosis or personal history of any of the following conditions,
including:

1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated
FAP and Gardner's syndrome).

2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch
Syndrome").

3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers
Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome,
Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial
Hyperplastic Polyposis.

- Subject has a family history of:

1. Familial adenomatous polyposis (also referred to as "FAP").

2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch
Syndrome").

- Subjects with Cronkhite-Canada Syndrome.

- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

- Subject has any condition that in the opinion of the Investigator should preclude
participation in the study
We found this trial at
21
sites
Metairie, Louisiana 70006
Principal Investigator: George Catinis, MD
Phone: 504-456-8020
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191 Biltmore Avenue
Asheville, North Carolina 28801
Phone: 828-254-0881
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Austin, Texas 78726
Phone: 737-247-7240
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Beachwood, Ohio 44122
Principal Investigator: Michael Frankel, MD
Phone: 440-205-1225
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Elkridge, Maryland
Phone: 410-730-3399
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Evansville, Indiana 47725
Principal Investigator: James Gutmann
Phone: 812-492-5071
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Evansville, IN
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Hartford, Connecticut 06016
Principal Investigator: Salam Zakko
Phone: 860-585-3838
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Huntington Beach, California 92647
Principal Investigator: Brian Siu, MD
Phone: 520-241-9435
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Lynchburg, Virginia 24502
Principal Investigator: Larry Clark, MD
Phone: 434-455-8659
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Lynchburg, VA
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Massillon, Ohio 44647
Principal Investigator: Raymond Mason, MD
Phone: 330-236-2285
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Massillon, OH
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Mentor, OH
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Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari
Phone: 318-807-0819
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Monroe, LA
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Xavier Llor
Phone: 203-200-4362
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Hyde Park, New York 11040
Principal Investigator: Nilesh Mehta
Phone: 347-944-9720
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Newburgh, Indiana 47630
Principal Investigator: Bradley Scheu
Phone: 812-492-5011
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Newburgh, IN
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Oak Lawn, Illinois 60453
Principal Investigator: Charles Berkelhammer
Phone: 281-517-0550
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Palm Springs, California 92262
Principal Investigator: Michael Jardula, MD
Phone: 760-325-2110
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Rockville, Maryland 20850
Phone: 301-417-8080
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Shreveport, Louisiana 71103
Phone: 318-525-3233
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2790 Godwin Boulevard
Suffolk, Virginia 23434
Principal Investigator: Pramod Malik, MD
Phone: 757-942-2566
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Wooster, Ohio 44691
Principal Investigator: Dana Bonezzi, MD
Phone: 330-202-3434
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