Clinical trial · Observational
Decision Counseling and Follow-up for Shield+ Patients
Decision Counseling and Follow-up (DCaF) for Shield+ Patients
NCT07620535CI-TRIAL-00113240DCaFnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Counseling Session | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SHIELD Positive with Completed Colonoscopy
- description
- Patients who are intending to undergo a complete a diagnostic evaluation
- interventionNames
- Behavioral: Decision Counseling Session
Primary outcomes (3)
- measure
- CDE Decisional Conflict
- timeFrame
- From Enrollment to the end of study at 6 months
- description
- 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.
- measure
- Factors for CDE Decisional Conflict
- timeFrame
- From Enrollment to End of Study at 6 months
- description
- Identify factors associated with CDE decisional conflict, intention, and preference following a positive Shield result.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.