Non-small Cell Lung Cancer MetastaticGEODENCT03477474
Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
An observational study of Non-small Cell Lung Cancer Metastatic, run by Guardant Health, Inc. at 1 site in United States.
Trial summary
The purpose of this registry is to collect data that describes the characteristics of people with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical outcomes after receiving their results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 1 Sep 2019
- How long will I take part?
- 2 Years
- 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: General Population Description: People With Advanced Cancer for whom the Guardant360 assay is ordered. Module 1 [NSCLC] Description: People with Advanced NSCLC for whom the Guardant360 assay is ordered.
Who may be able to join
- NSCLC, confirmed by histology or cytology
- Advanced disease, defined as: stage IIIB or IV NSCLC at the time of the qualifying Guardant360 blood collection; or for subjects with an initial diagnosis of Stage I-IIIA disease, NSCLC that is recurrent or metastatic at the time of the qualifying Guardant360 blood collection
- One of the following conditions at the time of the qualifying Guardant360 blood collection:
- No prior systemic therapy for advanced disease OR
- All three of the following conditions:
- 1. A history of prior systemic therapy for advanced disease, 2. Disease progression within the previous four weeks, \& 3. No new systemic therapy for advanced disease
- Exclusion Criteria Subjects with a diagnosis or history of any cancer involving the lung that is not classified as NSCLC, including but not limited to small cell carcinoma, neuroendocrine or carcinoid tumor, lymphoma, mesothelioma, metastatic non-lung carcinoma, or cancer of unknown primary.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this registry is to collect data that describes the characteristics of people with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical outcomes after receiving their results.
Read the detailed description
This is a prospective, descriptive registry of people with advanced cancer for whom a Guardant360 assay has been ordered by their health care providers. The registry is divided into modules according to primary cancer diagnosis. Module 1 includes subjects with advanced NSCLC with additional modules added later in the study.
All eligible people for whom blood for a Guardant360 assay has been collected will be invited to participate in the registry. Subject demographics and relevant medical history will be collected at the time of enrollment. Information on tumor molecular testing, treatment decisions, and clinical outcomes from the time of enrollment will be collected in a prospective manner. The registry does not require any specific treatments or procedures but rather collects information on the treatment journey of each participant. Subjects may participate in other clinical studies while also participating in GEODE.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- Guardant Health
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate Progression Free Survival (PFS)
Measured: 24 Months
Secondary outcomes (10)
Duration of treatment response
Measured: 24 Months
Time of tumor progression
Measured: 24 Months
time to treatment failure
Measured: 24 Months
Overall survival
Measured: 24 Months
Turnaround time for Guardant360 and tissue based genomic testing
Measured: 24 Months
Molecular alteration discovery rates for various alterations
Measured: 24 Months
Tumor response rates
Measured: 24 Months
Quantity not sufficient rescue rates
Measured: 24 Months
Tissue incomplete rescue rate
Measured: 24 Months
The rate at which treatment plans are changed following results of the Guardant360 test
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start6 Apr 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Alternative data published
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies 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
- 311 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Guardant Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477474
- Sponsor's protocol ID
- 01-MX-003
- Acronym
- GEODE
- Status last verified
- Oct 2019
- First submitted
- 13 Mar 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03477474
- Acronym / sponsor ID
- GEODE / 01-MX-003
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- Guardant Health
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Alternative data published
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Guardant Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 26 Mar 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.
The purpose of this registry is to collect data that describes the characteristics of people with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical outcomes after receiving their results.
Detailed description
This is a prospective, descriptive registry of people with advanced cancer for whom a Guardant360 assay has been ordered by their health care providers. The registry is divided into modules according to primary cancer diagnosis. Module 1 includes subjects with advanced NSCLC with additional modules added later in the study.
All eligible people for whom blood for a Guardant360 assay has been collected will be invited to participate in the registry. Subject demographics and relevant medical history will be collected at the time of enrollment. Information on tumor molecular testing, treatment decisions, and clinical outcomes from the time of enrollment will be collected in a prospective manner. The registry does not require any specific treatments or procedures but rather collects information on the treatment journey of each participant. Subjects may participate in other clinical studies while also participating in GEODE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General Population Description: People With Advanced Cancer for whom the Guardant360 assay is ordered. Module 1 [NSCLC] Description: People with Advanced NSCLC for whom the Guardant360 assay is ordered.
Key inclusion criteria (7 listed)
- NSCLC, confirmed by histology or cytology
- Advanced disease, defined as: stage IIIB or IV NSCLC at the time of the qualifying Guardant360 blood collection; or for subjects with an initial diagnosis of Stage I-IIIA disease, NSCLC that is recurrent or metastatic at the time of the qualifying Guardant360 blood collection
- One of the following conditions at the time of the qualifying Guardant360 blood collection:
- 1. A history of prior systemic therapy for advanced disease, 2. Disease progression within the previous four weeks, \& 3. No new systemic therapy for advanced disease
- Exclusion Criteria Subjects with a diagnosis or history of any cancer involving the lung that is not classified as NSCLC, including but not limited to small cell carcinoma, neuroendocrine or carcinoid tumor, lymphoma, mesothelioma, metastatic non-lung carcinoma, or cancer of unknown primary.
Key exclusion criteria (0 listed)
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
Estimate Progression Free Survival (PFS)
Time frame: 24 Months
10 secondary outcomes
Duration of treatment response
Time frame: 24 Months
Time of tumor progression
Time frame: 24 Months
time to treatment failure
Time frame: 24 Months
Overall survival
Time frame: 24 Months
Turnaround time for Guardant360 and tissue based genomic testing
Time frame: 24 Months
Molecular alteration discovery rates for various alterations
Time frame: 24 Months
Tumor response rates
Time frame: 24 Months
Quantity not sufficient rescue rates
Time frame: 24 Months
Tissue incomplete rescue rate
Time frame: 24 Months
The rate at which treatment plans are changed following results of the Guardant360 test
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: Alternative data published). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-small Cell Lung Cancer Metastatic, 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?
The sponsor lists 7 inclusion and 0 exclusion criteria. 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: stopped early, as of the sponsor's last update on 10 Oct 2019. 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 was stopped early (reason given: Alternative data published). Results are not available in the source record.
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?
Estimate Progression Free Survival (PFS) (time frame: 24 Months). 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 10 Oct 2019.