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

NCT07398456 | Not Yet Recruiting

• 1 other identifier: IRB TBD
• Study Type: interventional
• Target: 5,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer (CRC) Screening

Keywords

blood-based screening test; cancer risk; colorectal cancer risk; circulating tumor DNA; cell-free DNA; colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

• Blood-Based Screening Test (BBST) Follow-Up

  Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST.

  1 year after initial result

Secondary Outcomes (3)

• Patient Screening Test Preference

  1 year

• Screening Rates

  1 year

• Intervention Efficacy

  1 year

Other Outcomes (4)

• Baseline BBST Results

  1 year

• Follow-Up BBST Results

  1 year after initial result

• BBST+ Follow-Up

  1 year

Study Arms (2)

App Intervention

EXPERIMENTAL

Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.

Other: Educational Information via Smartphone App

Standard Support

NO INTERVENTION

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.

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.

App Intervention

Eligibility Criteria

• Age: 45 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center, Baylor Charles A Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Page E Blas, MA

CONTACT

214-820-5424; page.blas@bswhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients testing positive via BBST will be randomized based on clinic location such that half of the patients receive the intervention and the other half do not.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 10, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)