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Slow accrual
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The purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.
Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results.
A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid biopsy | Experimental | A liquid biopsy is a test will be done on a sample of blood to look for cancer cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid biopsy | Diagnostic Test | Liquid biopsy done on a blood draw, taking approximately 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| TTT measured in days | TTT measured in days - TTT will be summarized using mean, SD, and range. One sample t-test will be used to compare observed TTT against the null (30 days). | An average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to actionable genetic testing results | Time to actionable genetic testing results (ctDNA or tissue). Negative results with ctDNA testing will still require tissue confirmation, while positive results will be considered actionable without further testing. | An average of 30 days |
| Rate of actionable biomarker discovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Pennell, MD, PhD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44915 | United States |
All IPD that underlies the publication
Shortly after completion of the study which is to take approximately one year
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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Rate of actionable biomarker discovery, defined as the percentage of tested patients who have a detected genetic marker that is associated with either 1) an FDA-approved targeted treatment or 2) a targeted treatment available through a clinical trial. |
| An average of 30 days |
| Rate of appropriate guideline-directed therapy based upon testing results | Rate of appropriate guideline-directed therapy based upon testing results | An average of 30 days |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |