Brief 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.
Brief Title
Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Non-small Cell Lung Cancer Metastatic
Eligibility Criteria
General Inclusion Criteria:
1. 18 Years of age or older
2. Ability to provide written informed consent
3. Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment
General Exclusion Criteria
1. Pregnancy at the time of the qualifying Guardant360 blood collection
2. History of the allogeneic organ or tissue transplant
Module 1 (Non-Small Cell Lung Cancer)
Inclusion Criteria
1. NSCLC, confirmed by histology or cytology
2. 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
3. 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.
1. 18 Years of age or older
2. Ability to provide written informed consent
3. Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment
General Exclusion Criteria
1. Pregnancy at the time of the qualifying Guardant360 blood collection
2. History of the allogeneic organ or tissue transplant
Module 1 (Non-Small Cell Lung Cancer)
Inclusion Criteria
1. NSCLC, confirmed by histology or cytology
2. 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
3. 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.
Inclusion Criteria
Inclusion Criteria:
1. 18 Years of age or older
2. Ability to provide written informed consent
3. Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment
Inclusion Criteria
1. NSCLC, confirmed by histology or cytology
2. 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
3. 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
1. 18 Years of age or older
2. Ability to provide written informed consent
3. Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment
Inclusion Criteria
1. NSCLC, confirmed by histology or cytology
2. 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
3. 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
Gender
All
Gender Based
false
Keywords
Guardant Health
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03477474
Org Class
Industry
Org Full Name
Guardant Health, Inc.
Org Study Id
01-MX-003
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
Primary Outcomes
Outcome Measure
Estimate Progression Free Survival (PFS)
Outcome Time Frame
24 Months
Secondary Outcomes
Outcome Time Frame
24 Months
Outcome Measure
Duration of treatment response
Outcome Time Frame
24 Months
Outcome Measure
Time of tumor progression
Outcome Time Frame
24 Months
Outcome Measure
time to treatment failure
Outcome Time Frame
24 Months
Outcome Measure
Overall survival
Outcome Time Frame
24 Months
Outcome Measure
Turnaround time for Guardant360 and tissue based genomic testing
Outcome Time Frame
24 Months
Outcome Measure
Molecular alteration discovery rates for various alterations
Outcome Time Frame
24 Months
Outcome Measure
Tumor response rates
Outcome Time Frame
24 Months
Outcome Measure
Quantity not sufficient rescue rates
Outcome Time Frame
24 Months
Outcome Measure
Tissue incomplete rescue rate
Outcome Time Frame
24 Months
Outcome Measure
The rate at which treatment plans are changed following results of the Guardant360 test
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Phone