Status:
TERMINATED
Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
Lead Sponsor:
Guardant Health, Inc.
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- General Inclusion Criteria:
- 18 Years of age or older
- Ability to provide written informed consent
- Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment
- General Exclusion Criteria
- Pregnancy at the time of the qualifying Guardant360 blood collection
- History of the allogeneic organ or tissue transplant
- Module 1 (Non-Small Cell Lung Cancer)
- Inclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
April 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT03477474
Start Date
April 6 2018
End Date
September 1 2019
Last Update
October 10 2019
Active Locations (1)
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1
Holy Cross
Fort Lauderdale, Florida, United States, 33308