Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast (ES2018-07)
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
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).
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply
- Subject is male or female, 40 years of age or older.
- 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.
- 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.
- 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.
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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.
- Less than 7 days between colonoscopy and blood and stool sample collection.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool collection.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
To learn more, visit ClinicalTrials.Gov
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