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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer (CRC) Screening
• Intervention / Treatment: Other: Educational Information via Smartphone App

• Study Type: Interventional
• Enrollment (Estimated): 5500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Page E Blas, MA; Phone Number: 214-820-5424; Email: page.blas@bswhealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
      • Contact: Page E Blas, MA; Phone Number: 214-820-5424; Email: page.blas@bswhealth.org
      • Principal Investigator: Ronan Kelly, MD MBA FASCO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App Intervention; Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.	Other: Educational Information via Smartphone App; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Screening Test Preference	Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities.	1 year
Screening Rates	Compare the overall screening rates in the study population to a historical cohort in which blood-based testing was not offered as an option.	1 year
Intervention Efficacy	Assess whether use of a digital patient navigation tool +/- traditional patient navigation leads to an increased rate of completion of colonoscopy in those with a positive blood or stool test.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline BBST Results	Number of positive and negative BBST results at baseline testing.	1 year
Follow-Up BBST Results	Number of positive and negative BBST results at follow-up test	1 year after initial result
BBST+ Follow-Up	Number of BBST positives who received follow-up colonoscopy	1 year
BBST+/Colonoscopy- Follow-Up	Percentage of BBST-positive/colonoscopy-negative patients who accept and complete the follow-up BBST after negative colonoscopy.	1 year after negative colonoscopy

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cell-free DNA; colorectal cancer screening; circulating tumor DNA; cancer risk; blood-based screening test; colorectal cancer risk
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB TBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No