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This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Risk for Recurrence That Accept Adjuvant Chemotherapy | Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study. |
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| High-Risk for Recurrence That Decline Adjuvant Chemotherapy | Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years. |
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| Low-Risk for Recurrence | Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DetermaRX | Diagnostic Test | A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death | Up to 5 years |
| Overall Survival | Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason. | Up to 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Malignancy | Fisher exact test will used to test association of both LCDT1™, NodifyXL2®, and CIZ1b™ blood tests with malignancy. | At 6 Months |
| Cancer Recurrence | Fisher exact test will used to test association of LCDT-1â„¢ blood test with cancer recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brianna Aponte | Contact | 813-745-0787 | Brianna.Aponte@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Lary A Robinson, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| At 6 Months |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |