NCT05187767

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

Impact of Circulating Tumor DNA on Early Cancer Detection and Evaluation of STAS in Patients With Ground Glass Opacities

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Spreading of Tumor
• Circulating Tumor Cell

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cf DNA and ct DNA	Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-01-01
• Completion: 2024-10-01
• First posted: 2022-01-12
• Last updated: 2022-11-08

Locations

1 site across 1 country: Italy