Non-small Cell Lung Cancer Metastatic Clinical Trial
— GEODEOfficial title:
Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
NCT number | NCT03477474 |
Other study ID # | 01-MX-003 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | April 6, 2018 |
Est. completion date | September 1, 2019 |
Verified date | October 2019 |
Source | Guardant Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 311 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Holy Cross | Fort Lauderdale | Florida |
Lead Sponsor | Collaborator |
---|---|
Guardant Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate Progression Free Survival (PFS) | 24 Months | ||
Secondary | Duration of treatment response | 24 Months | ||
Secondary | Time of tumor progression | 24 Months | ||
Secondary | time to treatment failure | 24 Months | ||
Secondary | Overall survival | 24 Months | ||
Secondary | Turnaround time for Guardant360 and tissue based genomic testing | 24 Months | ||
Secondary | Molecular alteration discovery rates for various alterations | 24 Months | ||
Secondary | Tumor response rates | 24 Months | ||
Secondary | Quantity not sufficient rescue rates | 24 Months | ||
Secondary | Tissue incomplete rescue rate | 24 Months | ||
Secondary | The rate at which treatment plans are changed following results of the Guardant360 test | 24 Months |
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