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NCT07398456
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Conditions: Colorectal Cancer (CRC) Screening
Sex: All
Ages: 45 Years – 84 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 5500
Sponsor: Baylor Research Institute
Location: Baylor University Medical Center, Baylor Charles A Sammons Cancer Center Dallas Texas
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07398456). StuddyBuddy aggregates publicly available trial information.