Decision Counseling and Follow-up for Shield+ Patients

NCT07620535 | Not Yet Recruiting

• 1 other identifier: 07-GI-008
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colo-rectal Cancer

Keywords

Colo-rectal Cancer; Screening

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From Enrollment to End of Study at 6 months

Study Arms (1)

SHIELD Positive with Completed Colonoscopy

Patients who are intending to undergo a complete a diagnostic evaluation

Behavioral: Decision Counseling Session

Interventions

Decision Counseling Session BEHAVIORAL

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.

SHIELD Positive with Completed Colonoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a recent clinically ordered Shield™ test result who received a positive (abnormal) screening (Shield+) result.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guardant Health, Inc.: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

Jefferson Center

Philadelphia, Pennsylvania, 19114, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Director of Clinical Trial Operations

CONTACT

855-698-8887; dcaf@guardanthealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)