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The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols.
Secondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malignant GGOs | Patients with histologically proven malignant pulmonary ground glass opacities (GGOs) |
| |
| Benign GGOs | Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cf DNA and ct DNA | Diagnostic Test | Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of cf DNA | Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0 | through study completion, an average of 2 year |
| Presence of ct DNA | Number of participants with of circulating tumor DNA using a lung pannel for genes: EGFR, KRAS, NRAS, TP53, SKT11, DDR2, PIK3CA, FGFR3, CTNNB1, MET, BRAF, ERBB2, SMAD4, PTEN, AKT, FGFR2, ERBB4, NOTCH1, FGFR1, ALK, IDH1, HRAS, IDH2, PDGFRA, RET, ROS1 | through study completion, an average of 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with radiological finding of pulmonary ground glass opacity of unknown origin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Anile, MD | Contact | +390649970220 | marco.anile@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Marco Anile, MD | University of Roma La Sapienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Unit, Sapienza University of Rome | Recruiting | Roma | Italy |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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patients serum from peripheral blood samples
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |