Lung cancer prevention screening program 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
This study is testing a new lung cancer screening program for heavy smokers in Italy to see if it helps catch the disease earlier and improve their chances of quitting smoking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7324 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milano, MI) |
| Trial ID | NCT05766046 on ClinicalTrials.gov |
What this trial studies
This prospective randomized multicentered clinical study aims to implement early diagnosis of lung cancer in high-risk heavy smokers in Italy. The study will develop a nationwide lung cancer prevention screening program, similar to existing programs for breast, colon, and cervical cancers. Participants will receive a smoking cessation program and undergo screening with low-dose computed tomography (LDCT) every two years, compared to standard annual screening. The study also seeks to evaluate the effectiveness of blood biomarkers in screening intervals.
Who should consider this trial
Good fit: Ideal candidates are active or former heavy smokers with a significant smoking history and no current tumors.
Not a fit: Patients with severe chronic diseases or psychiatric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce lung cancer mortality through early detection and effective smoking cessation strategies.
How similar studies have performed: Previous large-scale randomized trials have shown that early detection of lung cancer through CT can significantly reduce mortality, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe chronic disease (e.g. severe respiratory and/or renal and/or hepatic and/or cardiac failure) * Severe psychiatric problems * Abuse of alcohol or other substances (including previous)
Where this trial is running
Milano, MI
- Chiara Bovolenta — Milano, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Ugo Pastorino, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study coordinator: Chiara Bovolenta, PhD
- Email: chiara.bovolenta@istitutotumori.mi.it
- Phone: 0223903928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.