Lung Cancer Clinical Trial
Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
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 how VeriStrat test results influence doctors' decisions and patients' outcomes may help doctors to better treat NSCLC in the future. This study will also look to establish whether new investigational tests can help better predict the effectiveness of certain medications for certain patients. These new investigational tests are only for research purposes at this time.
Full 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 receptor (EGFR) wild-type (negative) or have unknown EGFR mutational status. This study will also attempt to further validate that VeriStrat test results stratify subjects by clinical outcomes in the real world, uncontrolled clinical setting while exploring whether certain therapeutic approaches may yield opportunities for further study.
Predictive tests that aid physician therapeutic decision making are critical for optimizing subject outcomes while minimizing toxicity and associated treatment costs. This study will provide data for the validation of immunotherapy tests currently being developed. Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor microenvironment, and the patient immune system. As such, a successful predictive test will reflect the complex interplay between tumor and host. The multivariate tests from Biodesix have the advantage of being able to assess this complex biology.
The information gained from this research will not only guide the adoption of the VeriStrat test and inform medical decision making, including treatment choice, but will allow the validation of additional mass-spectrometry-based proteomic tests.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There are 41 Locations for this study
Huntsville Alabama, 35805, United States
Tuscaloosa Alabama, 35401, United States More Info
Principal Investigator
Fayetteville Arkansas, 72703, United States More Info
Principal Investigator
Jonesboro Arkansas, 72401, United States More Info
Principal Investigator
Sub-Investigator
Pleasanton California, 94588, United States More Info
Principal Investigator
Norwich Connecticut, 06360, United States
Boca Raton Florida, 33486, United States More Info
Principal Investigator
Lake City Florida, 32024, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Newnan Georgia, 30265, United States More Info
Principal Investigator
Savannah Georgia, 31405, United States
Valdosta Georgia, 31602, United States More Info
Principal Investigator
Naperville Illinois, 60540, United States More Info
Principal Investigator
Peoria Illinois, 61615, United States More Info
Principal Investigator
Indianapolis Indiana, 46237, United States
Michigan City Indiana, 46360, United States More Info
Principal Investigator
Covington Louisiana, 70433, United States More Info
Principal Investigator
Shreveport Louisiana, 71105, United States More Info
Principal Investigator
Principal Investigator
Principal Investigator
Tupelo Mississippi, 38801, United States More Info
Principal Investigator
Bolivar Missouri, 65613, United States More Info
Principal Investigator
Rolla Missouri, 65401, United States More Info
Principal Investigator
Springfield Missouri, 65804, United States More Info
Principal Investigator
Omaha Nebraska, 68114, United States More Info
Principal Investigator
Belleville New Jersey, 07109, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Albany New York, 12206, United States More Info
Principal Investigator
Lake Success New York, 11042, United States
New York New York, 10016, United States More Info
Principal Investigator
Chapel Hill North Carolina, 27517, United States More Info
Principal Investigator
Goldsboro North Carolina, 27534, United States More Info
Principal Investigator
Greenville North Carolina, 27834, United States More Info
Principal Investigator
Principal Investigator
Canton Ohio, 44708, United States More Info
Principal Investigator
Massillon Ohio, 44646, United States More Info
Principal Investigator
Salem Oregon, 97301, United States More Info
Principal Investigator
Gettysburg Pennsylvania, 17325, United States
Greenville South Carolina, 29607, United States
Arlington Texas, 76012, United States
Fort Worth Texas, 76104, United States More Info
Principal Investigator
Principal Investigator
Fort Worth Texas, 76104, United States More Info
Principal Investigator
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States More Info
Principal Investigator
Richmond Virginia, 23230, United States More Info
Principal Investigator
Bellingham Washington, 98225, United States More Info
Principal Investigator
Tacoma Washington, 98405, United States More Info
Principal Investigator
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