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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03625557

Enrollment

Registered

2018-08-10

Start date

2019-04-30

Completion date

2020-04-16

Last updated

2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hematologic Malignancy

Keywords

Guardant Health, GRECO

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

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

Countries

United States

Outcome results