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Decision Counseling for Shield+ Colorectal Cancer Patients

This observational study is looking at how people make decisions after getting a positive Shield™ blood test result for colorectal cancer. Researchers will use a Decision Counseling Session to help you understand your options and goals. They want to see how this counseling affects your decision-making, any confusion you might have (decisional conflict), and your intention to get a complete diagnostic evaluation (CDE), which often includes a colonoscopy. The study will track these factors for 6 months. You may be able to join if you are 45-75 years old, have a valid Shield(+) test result, and can complete the study in English. The study aims to enroll 350 participants.

Study design
This is an observational study with 350 planned participants. It is designed to understand how patients make decisions after a positive Shield™ test.
What's involved
You would participate in a Decision Counseling Session and complete surveys. Your decision-making and follow-up will be tracked for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after enrollment to measure decisional conflict and other factors.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07620535

Decision Counseling and Follow-up for Shield+ Patients

Not Yet Recruiting
Not specifiedAges 45–75Observational
Guardant Health, Inc.
~350 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Decision Counseling Session

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CDE Decisional Conflict
Measured over From Enrollment to the end of study at 6 months
+2 more outcomes measured

Conditions

Colo-rectal Cancer

Explore related trials

Colorectal CarcinomaShield

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Director of Clinical Trial Operations
[email protected]
855-698-8887
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • CDE Decisional ConflictFrom 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 ConflictFrom 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 ConflictFrom Enrollment to End of Study at 6 months

    Identify factors associated with change in CDE preference, decisional conflict, intention, and preference.