Study rationale and design of the PEOPLHE trial

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2024年2月6日

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Gianluca Milanese,
Mario Silva,
Roberta Eufrasia Ledda,
Elisa Iezzi,
Chandra Bortolotto,
Letizia Antonella Mauro,
Adele Valentini,
Linda Reali,
Olivia Maria Bottinelli,
Adriana Ilardi,
Antonio Basile,
Stefano Palmucci,
Lorenzo Preda,
Nicola Sverzellati,
Lorenzo Aliotta,
Sebastiano Barbarino,
Santo Borzì,
Virginia Casotto,
Marco Catalano,
Domenico Maria Cavalieri,
Mariangela Clemenza,
Martina Contino,
Luca Crimi,
Bruno Curia,
Pasquale Favia,
Vita Ida Gallone,
Giulia Guicciardi,
Giuliana La Rosa,
Ludovica Leo,
Rebecca Mura,
Antonella Priore,
Lidia Ruongo,
Carlotta Scavone,
Carlotta Zilioli

摘要

Purpose

Lung cancer screening (LCS) by low-dose computed tomography (LDCT) demonstrated a 20–40% reduction in lung cancer mortality. National stakeholders and international scientific societies are increasingly endorsing LCS programs, but translating their benefits into practice is rather challenging. The “Model for Optimized Implementation of Early Lung Cancer Detection: Prospective Evaluation Of Preventive Lung HEalth” (PEOPLHE) is an Italian multicentric LCS program aiming at testing LCS feasibility and implementation within the national healthcare system. PEOPLHE is intended to assess (i) strategies to optimize LCS workflow, (ii) radiological quality assurance, and (iii) the need for dedicated resources, including smoking cessation facilities.

Methods

PEOPLHE aims to recruit 1.500 high-risk individuals across three tertiary general hospitals in three different Italian regions that provide comprehensive services to large populations to explore geographic, demographic, and socioeconomic diversities. Screening by LDCT will target current or former (quitting < 10 years) smokers (> 15 cigarettes/day for > 25 years, or > 10 cigarettes/day for > 30 years) aged 50–75 years. Lung nodules will be volumetric measured and classified by a modified PEOPLHE Lung-RADS 1.1 system. Current smokers will be offered smoking cessation support.

Conclusion

The PEOPLHE program will provide information on strategies for screening enrollment and smoking cessation interventions; administrative, organizational, and radiological needs for performing a state-of-the-art LCS; collateral and incidental findings (both pulmonary and extrapulmonary), contributing to the LCS implementation within national healthcare systems.