Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:3/3/2019
Start Date:December 20, 2018
End Date:December 2019
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 the detection of colorectal cancer (CRC).

Subjects will be men and women, 40 years of age or older, with a diagnosis of CRC, at any
stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious
for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.

Inclusion Criteria:

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

2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a
colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile
serrated adenoma) or CRC on a pre-enrollment colonoscopy.

3. Post-colonoscopy, the residual lesion in the colon must be at least 1 cm in size as to
require additional surgical excision or complex colonoscopic polypectomy.

4. 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. 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.

2. Less than 7 days between colonoscopy and blood and stool sample collection.

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

4. Subject has any condition that in the opinion of the Investigator should preclude
participation in the study.
We found this trial at
2
sites
Rockville, Maryland 20850
Principal Investigator: Robert Hardi, MD
Phone: 301-417-8080
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Mentor, Ohio 44060
Principal Investigator: Don Brinberg, MD
Phone: 440-205-1225 x 212
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Mentor, OH
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