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

ID#: NCT03789162

Age: 40 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: December 20, 2018

End Date: December 01, 2020

Contact Information:
Amber Cheng
Summary: 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).

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.