NCT03625557

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

August 7, 2018

Last Update Submit

April 16, 2020

Conditions

Non-Hematologic Malignancy

Keywords

Guardant HealthGRECO

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

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

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guardant Health

Redwood City, California, 94063, United States

Location

Study Officials

  • Kathryn Lang, MBBS, MRCP, FRCPath

    Guardant Health, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

April 30, 2019

Primary Completion

February 1, 2020

Study Completion

April 16, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

US(1)