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Clinical Trials in the USA / NCT07620535
Starting soon Observational

Decision Counseling and Follow-up for Shield+ Patients

NCT07620535 · tracked via the Priya Life Science USA tracker
Sponsor
Guardant Health, Inc
Phase
Observational
Started
2026-06
Last updated
2026-06-02

Condition(s) studied

Colo-rectal Cancer

Investigational drug(s) / intervention(s)

Decision Counseling Session

Decision Counseling Session: 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 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • CDE Decisional Conflict — 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 — 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 — From Enrollment to End of Study at 6 months
    Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.

Trial sites (1)

FacilityCityRegionStatus
Jefferson Center Philadelphia Pennsylvania

More Guardant Health, Inc. trials in the USA

Shield Post-Approval Study Protocol Recruiting
Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode Active, not recruiting
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation Recruiting
Screening for High Frequency Malignant Disease Active, not recruiting
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation Recruiting

Other trials for the same condition

Shield Post-Approval Study Protocol Recruiting
Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors Recruiting
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients Active, not recruiting
Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07620535 on ClinicalTrials.gov ↗ ← All trials in the USA