Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Tes… (NCT07398456) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
United States5,500 participantsStarted 2026-06
Plain-language summary
The goal of this prospective implementation study is to understand the impact of a blood-based screening test (BBST) for colorectal cancer (CRC) on patient acceptability of and adherence to CRC screening as well as the rate of follow-up BBST in those with negative BBST at a 1-year interval.
Additional aims include assessing the impact of digital patient navigation intervention on the rate of follow-up colonoscopy in individuals with positive BBST. Patients will be randomized into the non-intervention arm or the intervention with an app arm.
Who can participate
Age range
45 Years – 84 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:
* patients aged 45-84 years of age
* Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
* If a patient opts for BBST, they are able and willing to provide blood samples per protocol
* Ability to understand and the willingness to participate in the study
* Must have been seen in HTPN clinic within the past 24 months from study activation
* Must have active MyBSW app portal account and/or establish account during study recruitment
Exclusion Criteria:
* Patients with a personal history of CRC
* Patients with a known high-risk family history of CRC precluding the patient from being average risk
* Patients with known diagnosis of inflammatory bowel disease or history of polyps
* Patients who are currently symptomatic for CRC such as: blood in the stool
* Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
* Have a recorded up to date CRC screening in the EMR (within 1 year for FIT, 3 years for mt-sDNA, 10 years for colonoscopy)
* Patients with a previous abnormal colonoscopy finding who are due for surveillance.
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.