Lung Cancer Prevention Screening Programme in Italy

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.

Conditions

• Lung Cancer
• COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
• Cardiovascular Diseases

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

Sponsors & Collaborators

• Presidio Ospedaliero Santo Spirito, Pescara

  collaborator UNKNOWN

• IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza

  collaborator UNKNOWN

• Azienda Ospedaliera Pugliese Ciaccio

  collaborator OTHER

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  collaborator NETWORK

• Azienda Ospedaliera dei Colli

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Parma

  collaborator OTHER

• IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia, Reggio Emilia

  collaborator UNKNOWN

• Istituto Nazionale dei Tumori Regina Elena, Roma

  collaborator UNKNOWN

• Ospedale Policlinico San Martino

  collaborator OTHER

• A.O. Ospedale Papa Giovanni XXIII

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Ospedali Riuniti

  collaborator OTHER

• Azienda Sanitaria Universitaria Integrata del Trentino

  collaborator OTHER

• San Luigi Gonzaga Hospital

  collaborator OTHER

• Istituto Tumori Giovanni Paolo II, BARI

  collaborator UNKNOWN

• Azienda Ospedaliera per l'Emergenza Canizzaro

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Istituto Oncologico Veneto IRCCS

  collaborator OTHER

• Ugo Pastorino

  lead OTHER

Principal Investigators

• Ugo Pastorino, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-17

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Italy

Study Locations