Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs

Recruiting

• Conditions: Lung Cancer; Circulating Tumor Cell; Spreading of Tumor
• Interventions: Diagnostic Test: cf DNA and ct DNA

• Registration Number: NCT05187767
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-12-24
• Study First Posted: 2022-01-12
• Study Start: 2022-04-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08
• Primary Completion: 2024-01
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malignant GGOs	cf DNA and ct DNA	Patients with histologically proven malignant pulmonary ground glass opacities (GGOs)
Benign GGOs	cf DNA and ct DNA	Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Thoracic Surgery Unit, Sapienza University of Rome; 🇮🇹 Roma, Italy