Status:
ACTIVE_NOT_RECRUITING
Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
Lead Sponsor:
Biodesix, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect information about how a doctor uses the results of the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients. Understanding h...
Detailed Description
The primary purpose of this observational study is to assess the physician's clinical practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are epidermal growth factor re...
Eligibility Criteria
Inclusion
- Subject must be 18 years of age or older at time of signing informed consent form (ICF).
- A diagnosis of NSCLC.
- Subject is willing to provide serum samples for VeriStrat testing.
- EGFR mutation status wild-type (negative) or a tested unknown.
- For subjects with untested/unknown EGFR status only: The subject must be willing to provide blood samples for GeneStrat testing.
- Subject is willing to provide serum samples for research, understanding that no test results will be made available either to the subject or the treating physician.
- Subject is able to read and understand the ICF and agrees to comply with study procedures and requirements.
Exclusion
- 1\. Subject's ability to understand the requirements of the protocol or to provide informed consent is impaired or subject is unwilling to comply with the protocol requirements.
Key Trial Info
Start Date :
April 4 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
5006 Patients enrolled
Trial Details
Trial ID
NCT03289780
Start Date
April 4 2016
End Date
December 1 2025
Last Update
September 19 2025
Active Locations (42)
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1
Oncology Specialties, PC; Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center
Tuscaloosa, Alabama, United States, 35401
3
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
4
St. Bernards Cancer Center Hematology / Oncology
Jonesboro, Arkansas, United States, 72401