Colorectal Cancer (CRC) ScreeningSHIELD-TXNCT07398456
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
A study testing Educational Information via Smartphone App in people with Colorectal Cancer (CRC) Screening, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC) Screening
- What is being tested?
- Educational Information via Smartphone App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246
Page E Blas, MA, 214-820-5424, page.blas@bswhealth.org
Ronan Kelly, MD MBA FASCO
About this study
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
- Being tested
- Educational Information via Smartphone App
- Keywords
- blood-based screening test, cancer risk, colorectal cancer risk, circulating tumor DNA, cell-free DNA, colorectal cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Information via Smartphone AppOther
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 group | Role | What they receive |
|---|---|---|
| App Intervention | Experimental | Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after initial result
Secondary outcomes (3)
Patient Screening Test Preference
Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC) ScreeningStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398456
- Sponsor's protocol ID
- 026-233
- Acronym
- SHIELD-TX
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
- ClinicalTrials.gov ID
- NCT07398456
- Acronym / sponsor ID
- SHIELD-TX / 026-233
- Conditions
- Colorectal Cancer (CRC) Screening
- Keywords
- blood-based screening test, cancer risk, colorectal cancer risk, circulating tumor DNA, cell-free DNA, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| App Intervention | Experimental | Other: Educational Information via Smartphone AppPatients on the app intervention arm will receive educational messages via their healthcare portal 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. |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Information via Smartphone AppThe 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. | Other | App Intervention |
Primary outcome
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.
3 secondary outcomes
Patient Screening Test Preference
Time frame: 1 year
Screening Rates
Time frame: 1 year
Intervention Efficacy
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Information via Smartphone App in people with Colorectal Cancer (CRC) Screening, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Page E Blas, MA (214-820-5424, page.blas@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-Based Screening Test (BBST) Follow-Up (time frame: 1 year after initial result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.