Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT07398456
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer (CRC) Screening

Eligibility Criteria

Sex
ALL
Age
45 Years - 84 Years
Healthy Volunteers
Accepted

Interventions

  • Educational Information via Smartphone App — OTHER
    The educational messages will include information about the meaning of a positive test result, the patient's chances of having a CRC detected on colonoscopy, and the importance of early CRC detection.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
5,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: App Intervention
    Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.
  • No Intervention: Standard Support
    Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and/or do not schedule a colonoscopy within 2 weeks of the blood test result will receive the standard patient navigation support offered which typically includes explanation and education regarding their positive test result and referral to a gastroenterologist or other proceduralist for a colonoscopy.

Primary Outcome Measure

Blood-Based Screening Test (BBST) Follow-Up [ Time Frame: 1 year after initial result ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical Center, Baylor Charles A Sammons Cancer CenterDallasTexas75246
Page E Blas, MA
[email protected]
214-820-5424
Ronan Kelly, MD MBA FASCO (PRINCIPAL_INVESTIGATOR)

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By research site
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center· Dallas, TX

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