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.
Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer [clinical stage IA-IB (cT1a-T2aN0), <4cm diameter].
If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
>18 years old, male or female.
Participants who are actively receiving any cancer treatment.
Participants with uncontrolled intercurrent illness.
Prior lung cancer within 5 years.
Current active other major cancer except non-melanoma skin cancer.
Patients seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.
Case-only
Prospective
DetermaRX
Diagnostic testA 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.
Disease Free Survival
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
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.
Tumor Malignancy
Fisher exact test will used to test association of both LCDT1™, NodifyXL2®, and CIZ1b™ blood tests with malignancy.
Cancer Recurrence
Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.
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