Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study

Inclusion Criteria:

* Cohort 1: Prospective Cohort Inclusion criteria - All Participants must meet the following criteria to be included in the study:

  1. Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
  2. Age 45 or older at time of consent
  3. Documented positive result from a mt-sDNA test obtained as part of routine clinical care within 12 months of blood draw
  4. Scheduled and intends to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care
  5. Considered by a physician as being of average risk for CRC
  6. Willing to provide an investigational blood draw prior to undergoing bowel preparation administration and colonoscopy.
* Cohort 2: Confirmed Case Cohort Inclusion criteria - All Participants must meet the following criteria to be included in the study:

  1. Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
  2. Age 45 or older at time of consent
  3. Has a confirmed CRC diagnosis within 90 days prior to signing the informed consent form, based on standard diagnostic procedures
  4. Must remain treatment-naïve for the current malignancy (no surgical resection, neoadjuvant chemotherapy, or radiation therapy has occurred since diagnosis)

Exclusion Criteria:

* Cohort 1: Prospective Cohort Exclusion Criteria - Participants who meet any of the following criteria will be excluded from study entry:

  1. Undergoing colonoscopy for investigation of symptoms such as rectal bleeding, blood in stool, or significant recent changes in stool habits
  2. History of CRC or AA diagnosed prior to the index mtsDNA positive test result
  3. 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)
  4. 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
  5. 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
  6. Is suffering from any febrile illness defined as a temperature \>101.5°F within 48 hours preceding the blood draw
  7. Participant is pregnant (self-reported)
  8. 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)
  9. Inability or unwillingness to comply with study procedures or follow-up requirements
  10. Previous or current participation in any study sponsored by, or employment with, Harbinger Health
  11. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
  12. Has any condition that in the opinion of the Investigator should preclude participation in the study
* Cohort 2: Confirmed Case Cohort Exclusion Criteria - Participants who meet any of the following criteria will be excluded from study entry:

  1. 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)
  2. Is suffering from any febrile illness defined as a temperature \>101.5°F within 48 hours preceding the blood draw
  3. Participant is pregnant (self-reported)
  4. 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)
  5. Inability or unwillingness to comply with study procedures or follow-up requirements
  6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health
  7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
  8. Has any condition that in the opinion of the Investigator should preclude participation in the study.