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ACTIVE NOT RECRUITING
NCT05766046
NA

Lung Cancer Prevention Screening Programme in Italy

Sponsor: Ugo Pastorino

View on ClinicalTrials.gov

Summary

This prospective randomized multicentered clinical study aims at implementing early diagnosis of lung cancer in high-risk heavy smokers in the Italian population. The main goal of the study is to develop a nationwide lung cancer prevention screening with high quality standard, similar to that of other screening programs i.e. breast, colon and cervix ongoing in Italy. The Italian Pulmonary Screening Network (RISP) includes 18 centers, which will promote primary prevention by offering a smoking cessation program (i.e. counselling and anti-smoking cytisine-based therapy) and secondary prevention by screening volunteers with chest Low Dose Computed Tomography (LDCT). The primary objective of the study is to demonstrate the non-inferiority of a risk-based screening strategy (less intensive, every 2 years) compared to the standard annual screening, in terms of stage I/II lung cancer incidence. Furthermore, the study aims to provide evidence whether blood biomarkers screening intervals can improve the efficiency of lung cancer screening by requiring less CT examinations while retaining the ability to diagnose lung cancer at curative state.

Official title: Early Diagnosis of Lung Cancer of the Italian Pulmonary Screening Network (RISP): Comparative Analysis for the Use of Low Dose Computed Tomography and Promotion of Primary Prevention Interventions in Subjects at High Risk for Lung Cancer

Key Details

Gender

All

Age Range

55 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

7324

Start Date

2022-09-17

Completion Date

2026-12-31

Last Updated

2026-03-27

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

early lung cancer detection

standard treatment for early lung cancer detection with LDCT at one or two years interval

OTHER

blood test

blood analysis for microRNA and other biomarkers detection

Locations (1)

Chiara Bovolenta

Milan, MI, Italy