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| Name | Class |
|---|---|
| Vector Oncology | OTHER |
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The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.
The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer. Once selected for the study and with full informed consent, patients will have a blood draw to allow the detection of cancer-related genomic alterations that are detectable within the blood sample. These results will be compared to results obtained from genomic profiling via standard tissue biopsy taken as part of routine care to help determine whether such 'liquid biopsies' can be used to guide treatments in future patients. The results of the liquid biopsy will not be used to guide treatment decisions in study participants.
In addition there is data-collection of treatments received for non small cell lung cancer and the response to these treatments during the first 6 months post tissue and blood analysis, though no additional visits or procedures are required for the patient beyond the initial blood draw.
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| Measure | Description | Time Frame |
|---|---|---|
| Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis | 1 year | |
| Proportion of NSCLC patients eligible for targeted therapy based on liquid biopsy analysis as an evaluation of feasibility molecular stratification, compared to standard of care alone |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata liquid biopsy assay | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC, who are intended to initiate first-line treatment according to standard guidelines, or having recently progressed on first-line EGFR or ALK directed therapy and being considered for further therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Ramaswamy Govindan, MD | Washington University School of Medicine | Principal Investigator |
| Edward Kim, MD | Atrium Health Levine Cancer Institute | Principal Investigator |
| Clive Morris, MD | Inivata | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facey Medical Foundation | Mission Hills | California | 91345 | United States | ||
| University of Colorado Cancer Center |
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A 40ml blood sample will be taken, from which Plasma and ultimately DNA will be prepared.
| 1 year |
| Progression free survival (PFS) rate over 6 months | 1 year |
| Overall survival (OS) rate over 6 months | 1 year |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Eastern CT Hematology Oncology | Norwich | Connecticut | 06360 | United States |
| Christiana Care Health Services Inc | Newark | Delaware | 19713 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Mid-Florida Hematology and Oncology Centers | Orange City | Florida | 32763 | United States |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | United States |
| Edward M Kaplan, MD & Associates | Skokie | Illinois | 60076 | United States |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| Norton Healthcare Inc | Louisville | Kentucky | 40202 | United States |
| Christus Cancer Treatment Center | Shreveport | Louisiana | 71105 | United States |
| Berkshire Hematology Oncology Services | Pittsfield | Massachusetts | 01201 | United States |
| Henry Ford Allegiance Health | Jackson | Michigan | 49201 | United States |
| Park Nicolett | Saint Louis Park | Minnesota | 55426 | United States |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | United States |
| Boone Hospital Center | Columbia | Missouri | 65201 | United States |
| Washington University (St. Louis) | St Louis | Missouri | 63110 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Northshore Hematology Oncology | East Setauket | New York | 11733 | United States |
| Northern Westchester Hospital Association | Mount Kisco | New York | 10549 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Levine Cancer Center | Mint Hill | North Carolina | 28227 | United States |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | United States |
| Trinity Cancer Center | Minot | North Dakota | 58701 | United States |
| Providence Health and Services | Portland | Oregon | 97213 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Carolina Blood and Cancer Care | Rock Hill | South Carolina | 29732 | United States |
| The West Clinic | Germantown | Tennessee | 38138 | United States |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37909 | United States |
| Thomas Spann Clinic Oncology | Corpus Christi | Texas | 78412 | United States |
| Hope Cancer Center of East Texas (Tyler Hem Onc) | Tyler | Texas | 75701 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | United States |
| Providence Regional Medical Center | Everett | Washington | 98201 | United States |
| University of Washington (Swedish General) | Seattle | Washington | 98104 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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