Clinical Trials in the USA / NCT03289780
Active, not recruiting
Observational
Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
NCT03289780 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Non-Small Cell Lung Cancer
Study 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.
Eligibility
Inclusion Criteria:
1. Subject must be 18 years of age or older at time of signing informed consent form (ICF).
2. A diagnosis of NSCLC.
3. Subject is willing to provide serum samples for VeriStrat testing.
4. EGFR mutation status wild-type (negative) or a tested unknown.
5. For subjects with untested/unknown EGFR status only: The subject must be willing to provide blood samples for GeneStrat testing.
6. 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.
7. 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.
Primary outcome measure(s)
- Physician Treatment Patterns Description — 3 years
Physician Treatment patterns Description: To describe physician treatment patterns pre and post-veriStrat testing. Describe the impact of the VeriStrat test results on treatment decisions, including but not limited to: percentage change in treatment decision, differences in chosen treatments between patients classified as VeriStrat good and those classified as VeriStrat Poor. Change in percentage of patients receiving systemic therapy or supportive therapies only.
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| Oncology Specialties, PC; Clearview Cancer Institute | Huntsville | Alabama | |
| Lewis & Faye Manderson Cancer Center at DCH Regional Medical Center | Tuscaloosa | Alabama | |
| Highlands Oncology Group | Fayetteville | Arkansas | |
| St. Bernards Cancer Center Hematology / Oncology | Jonesboro | Arkansas | |
| Valley Medical Oncology Consultants | Pleasanton | California | |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | |
| Boca Raton Regional Hospital -Lynn Cancer Institute | Boca Raton | Florida | |
| Lake City Cancer Care, LLC | Lake City | Florida | |
| South Eastern Regional Medical Center | Newnan | Georgia | |
| Summit Cancer Care | Savannah | Georgia | |
| South Georgia Medical Center | Valdosta | Georgia | |
| Edward-Elmhurst Healthcare | Naperville | Illinois | |
| Illinois Cancer Care | Peoria | Illinois | |
| Franciscan St. Francis Health | Indianapolis | Indiana | |
| Franciscan Health Woodland Cancer Center | Michigan City | Indiana | |
| Ponchartrain Cancer Center | Covington | Louisiana | |
| Christus Health | Shreveport | Louisiana | |
| North Mississippi Medical Center - Hematology and Oncology Clinic | Tupelo | Mississippi | |
| Central Care Cancer Center | Bolivar | Missouri | |
| Phelps County Regional Medical Center | Rolla | Missouri | |
| Mercy Medical | Springfield | Missouri | |
| Nebraska Methodist Hospital | Omaha | Nebraska | |
| Essex Oncology | Belleville | New Jersey | |
| New York Oncology Group | Albany | New York | |
| Clinical Research Associates | Lake Success | New York | |
| NYU Laura & Isaac Perlmutter Cancer Center | New York | New York | |
| University of North Carolina | Chapel Hill | North Carolina | |
| Southeastern Medical Oncology | Goldsboro | North Carolina | |
| Leo W. Jenkins Cancer Center - East Carolina University | Greenville | North Carolina | |
| Hematology and Oncology Associates - Mercy Medical Center | Canton | Ohio | |
| Tri-County Hematology & Oncology Associates | Massillon | Ohio | |
| Oregon Oncology Specialists (QCCA) | Salem | Oregon | |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | |
| Bon Secours St. Francis Cancer Center | Greenville | South Carolina | |
| Arlington Cancer Center | Arlington | Texas | |
| JPS Health Network, JPS Center for Cancer Care | Fort Worth | Texas | |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | |
| Scott & White Memorial Hospital and Clinic | Temple | Texas | |
| Huntsman Cancer Institute | Salt Lake City | Utah | |
| Virginia Cancer Institute | Richmond | Virginia |
+ 2 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03289780 on ClinicalTrials.gov ↗ ← All trials in the USA