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

University of Roma La Sapienza

Status: Enrolling

Conditions: Spreading of Tumor; Lung Cancer; Circulating Tumor Cell

Treatments: Diagnostic Test: cf DNA and ct DNA

Study type: Observational

Funder types: Other

Identifiers

NCT05187767

GGO ctDNA

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Malignant GGOs

Description:

Patients with histologically proven malignant pulmonary ground glass opacities (GGOs)

Treatment:

Diagnostic Test: cf DNA and ct DNA

Benign GGOs

Description:

Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs)

Treatment:

Diagnostic Test: cf DNA and ct DNA