Colo-rectal CancerDCaFNCT07620535
Decision Counseling and Follow-up for Shield+ Patients
An observational study of Colo-rectal Cancer, run by Guardant Health, Inc. at 1 site in United States.
Trial summary
Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Decision Counseling Session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2028
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with a recent clinically ordered Shield™ test result who received a positive (abnormal) screening (Shield+) result.
Who may be able to join
- Participant is 45-75 years old at the time of ShieldTM test order.
- Participant has a valid Shield(+) test result.
- Participant is willing and able to complete the informed consent process
- Participant is able to complete the informed consent process and decision counseling session in English
Who cannot join
- Participant is already enrolled in another Guardant Health, Inc. clinical study or has received a positive MCD result for a cancer type other than CRC.
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
Jefferson Center
Philadelphia, Pennsylvania, 19114
Principle Investigator, 215-503-4085, ronald.myers@jefferson.edu
About this study
Official title: Decision Counseling and Follow-up (DCaF) for Shield+ Patients
Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.
Read the detailed description
The DCaF study uses a prospective, observational design to characterize how patients make decisions following a Shield(+) screening result and to assess real-world adherence to recommended diagnostic colonoscopy. Because the intervention of interest is the patient's naturally occurring decision-making process-not the performance of the test itself-a non-interventional design is methodologically appropriate and minimizes participant burden. Incorporating decision counseling allows systematic evaluation of changes in preference, decisional conflict, and intention, while linkage to real-world evidence (RWE) claims data provides an efficient and objective method for determining colonoscopy completion. This approach enables the study to identify behavioral, clinical, and system-level factors associated with follow-up adherence without altering standard clinical care.
- Conditions
- Colo-rectal Cancer
- Being tested
- Decision Counseling Session
- Keywords
- Colo-rectal Cancer, 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.
Decision Counseling SessionBehavioural
During the decision counseling session, JH research staff will review the Complete Diagnostic Evaluation (CDE) infographic and use an online survey to guide the participant through a telephone encounter that involves the identification of patient goals that are likely to affect their decision to have CDE and not to have CDE.
| Study group | Role | What they receive |
|---|---|---|
| SHIELD Positive with Completed Colonoscopy | Patients who are intending to undergo a complete a diagnostic evaluation Receives: Behavioral: Decision Counseling Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDE Decisional Conflict
Determine the level of preference for, decisional conflict related to, intention to have CDE following a Shield+ result at baseline and after decision counseling and assess change.
Measured: From Enrollment to the end of study at 6 months
Factors for CDE Decisional Conflict
Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result.
Measured: From Enrollment to End of Study at 6 months
Factors for Changes in CDE Decisional Conflict
Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.
Measured: From Enrollment to End of Study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 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 Colo-rectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guardant Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620535
- Sponsor's protocol ID
- 07-GI-008
- Acronym
- DCaF
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Counseling and Follow-up (DCaF) for Shield+ Patients
- ClinicalTrials.gov ID
- NCT07620535
- Acronym / sponsor ID
- DCaF / 07-GI-008
- Conditions
- Colo-rectal Cancer
- Keywords
- Colo-rectal Cancer, Screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Guardant Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Jun 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.
Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.
Detailed description
The DCaF study uses a prospective, observational design to characterize how patients make decisions following a Shield(+) screening result and to assess real-world adherence to recommended diagnostic colonoscopy. Because the intervention of interest is the patient's naturally occurring decision-making process-not the performance of the test itself-a non-interventional design is methodologically appropriate and minimizes participant burden. Incorporating decision counseling allows systematic evaluation of changes in preference, decisional conflict, and intention, while linkage to real-world evidence (RWE) claims data provides an efficient and objective method for determining colonoscopy completion. This approach enables the study to identify behavioral, clinical, and system-level factors associated with follow-up adherence without altering standard clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHIELD Positive with Completed Colonoscopy | – | Behavioral: Decision Counseling SessionPatients who are intending to undergo a complete a diagnostic evaluation |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a recent clinically ordered Shield™ test result who received a positive (abnormal) screening (Shield+) result.
Key inclusion criteria (4 listed)
- Participant is 45-75 years old at the time of ShieldTM test order.
- Participant has a valid Shield(+) test result.
- Participant is willing and able to complete the informed consent process
- Participant is able to complete the informed consent process and decision counseling session in English
Key exclusion criteria (1 listed)
- Participant is already enrolled in another Guardant Health, Inc. clinical study or has received a positive MCD result for a cancer type other than CRC.
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 |
|---|---|---|
| Decision Counseling SessionDuring the decision counseling session, JH research staff will review the Complete Diagnostic Evaluation (CDE) infographic and use an online survey to guide the participant through a telephone encounter that involves the identification of patient goals that are likely to affect their decision to have CDE and not to have CDE. | Behavioural | SHIELD Positive with Completed Colonoscopy |
Primary outcome
CDE Decisional Conflict
Time frame: From Enrollment to the end of study at 6 months
Determine the level of preference for, decisional conflict related to, intention to have CDE following a Shield+ result at baseline and after decision counseling and assess change.
Factors for CDE Decisional Conflict
Time frame: From Enrollment to End of Study at 6 months
Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result.
Factors for Changes in CDE Decisional Conflict
Time frame: From Enrollment to End of Study at 6 months
Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.
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 Jun 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Colo-rectal Cancer, run by Guardant Health, Inc. 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 1 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 Jun 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 Director of Clinical Trial Operations (855-698-8887, dcaf@guardanthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDE Decisional Conflict (time frame: From Enrollment to the end of study at 6 months). The study lists 3 primary outcomes in all. 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 Jun 2026.