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| Name | Class |
|---|---|
| Guardian Research Network, Inc. | OTHER |
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This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer
The primary aim of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | 1st line setting-approx. 150 patients. collect tissue biopsy per standard of care & one blood draw (40ml) | ||
| Arm B | 1st line setting- approx. 100 patients one blood draw (40ml) | ||
| Arm C | Approx. 10 patients tissue collection optional 3 blood draws (40ml) over 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis. | The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis | Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis | 12 months |
| Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital Cancer Center/Clinical Research | Fort Smith | Arkansas | 72903 | United States | ||
| Mercy Cancer Center |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis |
| 12 months |
| Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved | Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited (Quantity Not Sufficient) versus that observed where tumour biopsy is achieved. | 12 months |
| Joplin |
| Missouri |
| 64804 |
| United States |
| Mercy Clinic | Springfield | Missouri | 65804 | United States |
| Mercy Clinic Oncology & Hematology | Oklahoma City | Oklahoma | 73120 | United States |
| Lehigh Valley Health Networks | Allentown | Pennsylvania | 18103 | United States |
| Gibbs Cancer Center & Research Institute | Spartanburg | South Carolina | 29303 | United States |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |