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NCT05766046Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
7324 (estimated)
First submitted
1 Mar 2023
Start date
17 Sept 2022
Primary completion date
31 Dec 2026
Lead sponsor
Ugo Pastorino
Diseases
COPD, Lung cancer
NCT number
NCT05766046

What you commit to

  • Study type: Interventional
  • Planned participants: 7324
  • From 17 Sept 2022 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Abuse of alcohol or other substances (including previous)

Other illness

  • Severe chronic disease (e.g. severe respiratory and/or renal and/or hepatic and/or cardiac failure)
  • Severe psychiatric problems

Who the study is looking for

  • Active smoker (≥ 30 packs/year)
  • Former heavy smoker for ≤ 15 years (≥ 30 packs/year)
  • Absence of tumors for at least 5 years
  • Signature of informed consent for studio enrollment and processing of personal data

Age in the registry: 55 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chiara Bovolenta
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.