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OpenTrials
Completed

NCT Number: NCT03625557

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guardant Health

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 3 years

    Portion of patients with tumors that are found to have complete or partial response

Sponsors and collaborators

Lead sponsor

Guardant Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.