Clinical Research Trials

Key Trial Criteria

• 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.

• Exclusion Criteria

  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.