Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Malignant GGOs Patients with histologically proven malignant pulmonary ground glass opacities (GGOs) |
Diagnostic Test: cf DNA and ct DNA
Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA
|
| Benign GGOs Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs) |
Diagnostic Test: cf DNA and ct DNA
Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA
|
Outcome Measures
Primary Outcome Measures
- Quantification of cf DNA [through study completion, an average of 2 year]
Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0
- Presence of ct DNA [through study completion, an average of 2 year]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age> 18 years
-
radiological finding of pulmonary ground glass opacity
-
absence of solid or haematological tumor
Exclusion Criteria:
-
radio / chemotherapy treatment for at least 6 months
-
patient unable to understand and express his consent to the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thoracic Surgery Unit, Sapienza University of Rome | Roma | Italy |
Sponsors and Collaborators
- University of Roma La Sapienza
Investigators
- Principal Investigator: Marco Anile, MD, Sapienza University of Rome
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GGO ctDNA