Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
Location contact
Page E Blas, MA
CONTACT
Ronan Kelly, MD MBA FASCO
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07398456
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
45 year–84 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Educational Information via Smartphone App
OtherThe 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.
Primary outcomes
-
Blood-Based Screening Test (BBST) Follow-Up
Time frame: 1 year after initial result
Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST.
Secondary outcomes
-
Patient Screening Test Preference
Time frame: 1 year
Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities.
-
Screening Rates
Time frame: 1 year
Compare the overall screening rates in the study population to a historical cohort in which blood-based testing was not offered as an option.
-
Intervention Efficacy
Time frame: 1 year
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.
Other outcomes
-
Baseline BBST Results
Time frame: 1 year
Number of positive and negative BBST results at baseline testing.
-
Follow-Up BBST Results
Time frame: 1 year after initial result
Number of positive and negative BBST results at follow-up test
-
BBST+ Follow-Up
Time frame: 1 year
Number of BBST positives who received follow-up colonoscopy
-
BBST+/Colonoscopy- Follow-Up
Time frame: 1 year after negative colonoscopy
Percentage of BBST-positive/colonoscopy-negative patients who accept and complete the follow-up BBST after negative colonoscopy.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Baylor Research Institute
Other
Registry information
Acronym: SHIELD-TX
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 10, 2026
- Registry last updated
- Feb 12, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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