Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study

Exclusion Criteria20

• Undergoing colonoscopy for investigation of symptoms such as rectal bleeding, blood in stool, or significant recent changes in stool habits
• History of CRC or AA diagnosed prior to the index mtsDNA positive test result
• History of any malignancy (patients who have undergone surgical removal of skin basal cell or squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of informed consent)
• Has been diagnosed with a condition associated with a high risk of CRC (including inflammatory bowel disease (IBD), chronic ulcerative colitis, Crohn's disease, or familial adenomatous polyposis) or has a family history of CRC, defined as having a first-degree relative (parent, sibling, or child) with a CRC diagnosis at any age
• Has been diagnosed with a relevant familial (hereditary) cancer syndrome that places them above average risk of CRC such as hereditary nonpolyposis CRC syndrome (or Lynch syndrome), Peutz-Jeghers syndrome, MYH-associated polyposis, Gardner's syndrome, Turcot's (or Crail's) syndrome, Cowden's syndrome, juvenile polyposis, Cronkhite-Canada syndrome, neurofibromatosis, or familial hyperplastic polyposis
• Is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours preceding the blood draw
• Participant is pregnant (self-reported)
• Recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Participants with a corneal transplant can be considered for study entry)
• Inability or unwillingness to comply with study procedures or follow-up requirements
• Previous or current participation in any study sponsored by, or employment with, Harbinger Health
• Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
• Has any condition that in the opinion of the Investigator should preclude participation in the study
• Has a history of any malignancy (patients who have undergone surgical removal of skin basal cell or squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of informed consent for the study)
• Is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours preceding the blood draw
• Participant is pregnant (self-reported)
• Is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Participants with a corneal transplant can be considered for study entry)
• Inability or unwillingness to comply with study procedures or follow-up requirements
• Previous or current participation in any study sponsored by, or employment with, Harbinger Health
• Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
• Has any condition that in the opinion of the Investigator should preclude participation in the study.