An observational study in Lung Cancer, Spreading of Tumor and Circulating Tumor Cell, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by University of Roma La Sapienza · Observational
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 80 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with radiological finding of pulmonary ground glass opacity of unknown origin
Exclusion Criteria:
Patients with histologically proven malignant pulmonary ground glass opacities (GGOs)
Diagnostic Test: cf DNA and ct DNA
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
Quantification of cf DNA
Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0
Time frame: 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
Time frame: through study completion, an average of 2 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Roma La Sapienza