A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:3/2/2019
Start Date:April 2015
End Date:July 2020

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A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at
3 years in average risk patients.

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at
3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved
labeling at baseline. Subjects with positive results will be referred to colonoscopy and
study participation completed. Subjects with negative Cologuard results will be seen annually
for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless
of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study
will be discontinued following collection of the colonoscopy and associated histopathology
results.

Inclusion Criteria:

1. Subject has been prescribed Cologuard for colorectal cancer screening

2. Subject is at average risk for development of colorectal cancer

3. Subject is 50 years or older

4. Subject willing and able to sign informed consent.

Exclusion Criteria:

1. Subject had a colonoscopy in the previous 9 years

2. Subject has undergone any double-contrast barium enema, virtual (CT-based)
colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.

3. Subject has had a positive fecal occult blood test or FIT within the previous six (6)
months.

4. Subject has any condition that in the opinion of the investigator should preclude
participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).

5. Subject has a history of colorectal cancer or advanced adenoma.

6. Subject has a history of aerodigestive tract cancer

7. Subject has had a prior colorectal resection for any reason other than sigmoid
diverticular disease

8. Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the
previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal
bleeding)

9. Subject has a diagnosis or personal history of any of the following high-risk
conditions for colorectal cancer:

- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and
Crohn's disease.

- 2 first-degree relatives who have been diagnosed with colon cancer. (Note:
first-degree relatives include parents, siblings and offspring).

- One first-degree relative with CRC diagnosed before the age of 60.

10. Subject has a family history of:

- Familial adenomatous polyposis (also referred to as "FAP", including attenuated
FAP).

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

- Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers
Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or
Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada
Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
We found this trial at
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Binghamton, New York 13901
Principal Investigator: Frank Eder, MD
Phone: 607-798-7345
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Seth Crockett, MD
Phone: 919-445-0203
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
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Atlanta, Georgia 30308
Principal Investigator: Robert S Kaufmann, MD
Phone: 678-702-0845
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Austin, Texas 78731
Principal Investigator: Anas Daghestani
Phone: 512-421-4818
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Carlsbad, California 92008
Principal Investigator: Gary Korff, MD
Phone: 760-547-2171
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Cincinnati, Ohio 45236
Principal Investigator: James Pritchard, MD
Phone: 513-488-1295
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Clearwater, Florida 33756
Principal Investigator: Miguel Trevino, MD
Phone: 727-584-6368
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Columbia, Maryland 21045
Principal Investigator: William Saway, MD
Phone: 704-996-4798
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Corona, California 92879
Principal Investigator: M. Mazen Jamal, MD
Phone: 951-220-4029
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Elkridge, Maryland 21075
Principal Investigator: Steven Geller, MD
Phone: 410-730-3399
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Endwell, New York 13760
Principal Investigator: Jonathan Harris, MD
Phone: 607-754-4081
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Evergreen Park, Illinois 60805
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Garden Grove, California 92840
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Glendale, Arizona 85308
Principal Investigator: Thomas Lenzmeier, MD
Phone: 623-295-1711
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Harleysville, Pennsylvania 19438
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Henderson, Nevada 89074
Principal Investigator: Ibrahim Fakhouri, MD
Phone: 702-462-8822
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Homestead, Florida 33030
Principal Investigator: Michael Feldman, MD
Phone: 786-339-8454
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Indianapolis, Indiana 46202
Principal Investigator: Thomas Imperiale, MD
Phone: 317-274-9321
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Jupiter, Florida 33458
Principal Investigator: Ronald Surowitz, DO
Phone: 561-741-2033
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
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Los Angeles, California 90095
Principal Investigator: Folasade May, MD, PhD
Phone: 310-505-4077
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Meridian, Idaho 83642
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Mesa, Arizona 85206
Principal Investigator: Tami Bruce, MD
Phone: 480-751-2480
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Miami, Florida 33134
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Miami, Florida 33144
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Mission Hills, California 91345
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Montgomery, Texas 77356
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Newport Beach, California 92663
Principal Investigator: John Homan, MD
Phone: 760-421-2993
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Oxnard, California 93030
Principal Investigator: Augusto Focil
Phone: 805-483-1185
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Oxnard, California 93030
Principal Investigator: Karen Simon, MD
Phone: 805-483-1185
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Palm Springs, California 92262
Principal Investigator: Michael Jardula, MD
Phone: 760-320-9505
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Pompano Beach, Florida 33060
Principal Investigator: Daniel Lindenberg, MD
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Port Saint Lucie, Florida 34984
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Rochester, Minnesota 55905
Principal Investigator: Seth Sweetser, MD
Phone: 507-538-1730
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Sacramento, California 95825
Principal Investigator: Kayvan Haddadan, MD
Phone: 888-543-2243
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Salt Lake City, Utah 84107
Principal Investigator: James Wood, MD
Phone: 801-288-0607
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Tempe, Arizona 85283
Principal Investigator: Thomas Fiel, DO
Phone: 480-831-6328
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Wooster, Ohio 45150
Principal Investigator: Raymond Mason, MD
Phone: 330-345-2008
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