Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records

Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records (GRECO)

To document the clinical outcomes of cancer patients who received the Guardant360® test and agree to share their records with Guardant Health.

Study Overview

• Status: Completed
• Conditions: Non-Hematologic Malignancy

Detailed Description

This is an observational study of clinical outcomes to be conducted in the United States. Patients with a diagnosis of Stage 3-4 advanced cancer who possess specific pathway mutations identified by the Guardant360® test will be eligible to enroll in the study. Patients will be recruited by telephone or email and/or through the Guardant Health Patient Portal to determine interest in the study. Should patients be interested in contributing to this registry study, they will be prompted to consent via a commercial service for patients to request, manage, and view their medical records. Enrolled participants will be requested to release copies of their medical records for review by the principal investigator. Study adminsitrators will abstract participant demographics, cancer-related therapies, and clinical outcomes for analysis.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Guardant Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with advanced cancer involving genetic pathway alterations identified through Guardant 360®.

Description

General Inclusion Criteria:

• Adults (≥ 18 years old) with a diagnosis of Stage 3 or Stage 4 cancer (non-hematologic malignancy). Patients with advanced cancers not typically staged 1-4 (such as extensive stage small lung cancer) may be enrolled.
• Results from Guardant360® test
• Patient has previously provided contact information (either email or phone) to Guardant Health.
• Able and wiling to complete the informed consent process.
• Willingness to consent to the release of medical records.
• Willingness to provide Medical Records Release

General Exclusion Criteria:

• Unwilling or unable to provide written informed consent.
• Unable to understand English.
• Diagnosis of NSCLC
• Guardant 360® test results released to the patient's physician no less than 14 days and no greater than 60 days prior to initial patient contact.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Portion of patients with tumors that are found to have complete or partial response	3 years

Collaborators and Investigators

• Sponsor: Guardant Health, Inc.
• Investigators: Principal Investigator: Kathryn Lang, MBBS, MRCP, FRCPath, Guardant Health

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Guardant Health; GRECO
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 01-MX-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No