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 range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)