Circulating Tumor Cell, Lung Cancer, Spreading of Tumor
Conditions
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.
Interventions
DIAGNOSTIC_TESTcf DNA and ct DNA
Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA
Sponsors
University of Roma La Sapienza
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactMarco Anile, MD
Outcome results
None listed