Cancer ColonNCT06119425
Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice Highlands
A study testing blood-based CRC screening in people with Cancer Colon, run by Ballad Health at 1 site in United States.
Trial summary
This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. Read more about this study
- Who is it for?
- Ages 45 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Colon
- What is being tested?
- blood-based CRC screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (inclusive)
- Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
- If a patient opts for blood-based test, they are able and willing to provide blood samples per protocol
- Ability to understand and the willingness to participate in the study
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
- Patients with a previous abnormal colonoscopy finding who are due for surveillance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johnson City Medical Center
Johnson City, Tennessee, 37604
About this study
Official title: Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice in the Outpatient Clinical Settings in the Appalachian Highlands
This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Read the detailed description
Study Rationale This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Although multiple screening options for CRC are available, participation and adherence to CRC screening remains below the national goal. CRC screening rate at the Ballad Health Mountain Laurel Internal Medicine clinic (site 1) is approximately 66%.
A blood-based test (BBT) can provide a clinically important complement to standard-of-care (SOC) screening tests and address unmet medical needs for patients, especially for those who are non-adherent with current screening modalities. There are economic and societal benefits in early detection and prevention of CRC in a broader population than the one currently up to date with screening. The unmet need for maximum participation in CRC screening could be addressed with blood-based testing.
Measuring subsequent provider experience and implementation behavior patterns involving blood based non-invasive cancer screening choices will also help to identify clinical utility of such test and implementation into clinical practice.
- Conditions
- Cancer Colon
- Being tested
- blood-based CRC screening
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood-based CRC screeningDiagnostic test
For this study, a commercially available blood-based CRC screening test will be used. The selected test is Shield (Guardant Health, Redwood City, California, USA). The Shield test was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, California, USA, which is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity clinical testing. The Shield test is currently commercially available as an laboratory developed test (LDT). Additionally, Guardant submitted the pre-market approval (PMA) application for the Shield test to the Food and Drug Administration (FDA) in March of 2023. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices. To this end, the Shield test is currently under review by the FDA.
| Study group | Role | What they receive |
|---|---|---|
| Screening Discussion and Election | No intervention | Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options. Patients who express a desire to be screened using the SOC options will be considered part of the control group. |
| Screening Selection | Experimental | Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options as well as the option to be screened with a blood-based test which is not currently standard of care. Patients who express a desire to be screened using the SOC options or the blood-based non-SOC option will be considered part of the experimental group. Receives: Diagnostic Test: blood-based CRC screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opted to be screened for CRC by either SOC or study diagnostic test
Number of participants who agree to be screened CRC. % of participants who agree to be screened for CRC.
Measured: 3 months
Secondary outcomes (1)
Opted to be screened by the study diagnostic test
Number of participants who opted to be screened by the study diagnostic test instead of
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start12 Oct 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColonStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ballad Health
- Sponsor type
- University, hospital or other
- Collaborators
- Guardant Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Karen J. Elmore, MD, Principal investigator, Ballad Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119425
- Sponsor's protocol ID
- 2082244-1
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice in the Outpatient Clinical Settings in the Appalachian Highlands
- ClinicalTrials.gov ID
- NCT06119425
- Acronym / sponsor ID
- 2082244-1
- Conditions
- Cancer Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Ballad HealthUniversity, hospital or other
- Collaborators
- Guardant Health, Inc.
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Nov 2023 (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.
This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Detailed description
Study Rationale This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Although multiple screening options for CRC are available, participation and adherence to CRC screening remains below the national goal. CRC screening rate at the Ballad Health Mountain Laurel Internal Medicine clinic (site 1) is approximately 66%.
A blood-based test (BBT) can provide a clinically important complement to standard-of-care (SOC) screening tests and address unmet medical needs for patients, especially for those who are non-adherent with current screening modalities. There are economic and societal benefits in early detection and prevention of CRC in a broader population than the one currently up to date with screening. The unmet need for maximum participation in CRC screening could be addressed with blood-based testing.
Measuring subsequent provider experience and implementation behavior patterns involving blood based non-invasive cancer screening choices will also help to identify clinical utility of such test and implementation into clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening Discussion and Election | No intervention | –Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options. Patients who express a desire to be screened using the SOC options will be considered part of the control group. |
| Screening Selection | Experimental | Diagnostic Test: blood-based CRC screeningPatients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options as well as the option to be screened with a blood-based test which is not currently standard of care. Patients who express a desire to be screened using the SOC options or the blood-based non-SOC option will be considered part of the experimental group. |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 45-84 years of age (inclusive)
- Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
- If a patient opts for blood-based test, they are able and willing to provide blood samples per protocol
- Ability to understand and the willingness to participate in the study
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 |
|---|---|---|
| blood-based CRC screeningFor this study, a commercially available blood-based CRC screening test will be used. The selected test is Shield (Guardant Health, Redwood City, California, USA). The Shield test was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, California, USA, which is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity clinical testing. The Shield test is currently commercially available as an laboratory developed test (LDT). Additionally, Guardant submitted the pre-market approval (PMA) application for the Shield test to the Food and Drug Administration (FDA) in March of 2023. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices. To this end, the Shield test is currently under review by the FDA. | Diagnostic test | Screening Selection |
Primary outcome
Opted to be screened for CRC by either SOC or study diagnostic test
Time frame: 3 months
Number of participants who agree to be screened CRC. % of participants who agree to be screened for CRC.
1 secondary outcome
Opted to be screened by the study diagnostic test
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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. This study is not recruiting at the moment.
Karen J. Elmore, MD principal investigator
Ballad Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood-based CRC screening in people with Cancer Colon, run by Ballad Health 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 4 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: finished, as of the sponsor's last update on 10 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opted to be screened for CRC by either SOC or study diagnostic test (time frame: 3 months). 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 10 Feb 2026.