Non-Hematologic MalignancyNCT03625557
Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records
An observational study of Non-Hematologic Malignancy, run by Guardant Health, Inc. at 1 site in United States.
Trial summary
To document the clinical outcomes of cancer patients who received the Guardant360® test and agree to share their records with Guardant Health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hematologic Malignancy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 16 Apr 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced cancer involving genetic pathway alterations identified through Guardant 360®.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Hematologic Malignancy
- Keywords
- Guardant Health, GRECO
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Portion of patients with tumors that are found to have complete or partial response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start30 Apr 2019
- Primary completion1 Feb 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Guardant Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Lang, MBBS, MRCP, FRCPath, Principal investigator, Guardant Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625557
- Sponsor's protocol ID
- 01-MX-002
- Status last verified
- Apr 2020
- First submitted
- 7 Aug 2018
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records (GRECO)
- ClinicalTrials.gov ID
- NCT03625557
- Acronym / sponsor ID
- 01-MX-002
- Conditions
- Non-Hematologic Malignancy
- Keywords
- Guardant Health, GRECO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Guardant Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced cancer involving genetic pathway alterations identified through Guardant 360®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate (ORR)
Time frame: 3 years
Portion of patients with tumors that are found to have complete or partial response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Lang, MBBS, MRCP, FRCPath principal investigator
Guardant Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hematologic Malignancy, run by Guardant Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.