Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study (NCT07479381) | Clinical Trial Compass
TerminatedNot Applicable
Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study
Stopped: Study terminated per sponsor decision due to operational reasons. The termination was not a result of any participant safety concerns.
United States14 participantsStarted 2026-03-20
Plain-language summary
The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC).
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. 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
✓. Age 45 or older at time of consent
✓. Documented positive result from a mt-sDNA test obtained as part of routine clinical care within 12 months of blood draw
✓. Scheduled and intends to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care
✓. Considered by a physician as being of average risk for CRC
✓. Willing to provide an investigational blood draw prior to undergoing bowel preparation administration and colonoscopy.
✓. 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
✓. Age 45 or older at time of consent
Exclusion criteria
✕. 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)