RecruitingNot ApplicableNCT05766046

Lung Cancer Prevention Screening Programme in Italy

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


Sponsor

Ugo Pastorino

Enrollment

7,324 participants

Start Date

Sep 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is offering lung cancer screening with low-dose CT scans to heavy smokers and recent ex-smokers in Italy, to detect lung cancer at an early and more treatable stage. You may be eligible if: - You currently smoke heavily (at least 30 pack-years — for example, a pack a day for 30 years), OR - You used to smoke heavily but quit within the last 15 years (still at least 30 pack-years) - You have been cancer-free for at least the past 5 years - You are willing to sign an informed consent form You may NOT be eligible if: - You have a severe chronic illness, such as severe lung disease, serious kidney or liver problems, or significant heart failure - You have severe psychiatric problems - You have a history of serious alcohol or drug abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTearly lung cancer detection

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

OTHERblood test

blood analysis for microRNA and other biomarkers detection


Locations(1)

Chiara Bovolenta

Milan, MI, Italy

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NCT05766046


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