Non-small Cell Lung Cancer Metastatic
Conditions
Keywords
Guardant Health
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.
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.
Interventions
None listed
Sponsors
Guardant Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate Progression Free Survival (PFS) | 24 Months |
Secondary
| Measure | Time frame |
|---|---|
| Time of tumor progression | 24 Months |
| time to treatment failure | 24 Months |
| Overall survival | 24 Months |
| Turnaround time for Guardant360 and tissue based genomic testing | 24 Months |
| Duration of treatment response | 24 Months |
| Tumor response rates | 24 Months |
| Quantity not sufficient rescue rates | 24 Months |
| Tissue incomplete rescue rate | 24 Months |
| The rate at which treatment plans are changed following results of the Guardant360 test | 24 Months |
| Molecular alteration discovery rates for various alterations | 24 Months |
Countries
United States
Outcome results
None listed