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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05187767
Other study ID # GGO ctDNA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date October 2024

Study information

Verified date November 2022
Source University of Roma La Sapienza
Contact Marco Anile, MD
Phone +390649970220
Email marco.anile@uniroma1.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
cf DNA and ct DNA
Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA

Locations

Country Name City State
Italy Thoracic Surgery Unit, Sapienza University of Rome Roma

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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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