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

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Chiara Bovolenta
RECRUITING
Milan
Contact Information
Primary
Chiara Bovolenta, PhD
chiara.bovolenta@istitutotumori.mi.it
0223903928
Time Frame
Start Date: 2022-09-17
Estimated Completion Date: 2026-09
Participants
Target number of participants: 7324
Treatments
Experimental: Standard arm
Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an annual interval (according to guidelines)
Experimental: Risk-based arm
Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an interval of two years.
Sponsors
Collaborators: A.O. Ospedale Papa Giovanni XXIII, Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento, Azienda Ospedaliera Pugliese Ciaccio, Istituto Oncologico Veneto IRCCS, IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia, Reggio Emilia, IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza, Azienda Ospedaliero-Universitaria di Parma, Istituto Tumori Giovanni Paolo II, BARI, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, San Luigi Gonzaga Hospital, Azienda Ospedaliero-Universitaria Careggi, Istituto Nazionale dei Tumori Regina Elena, Roma, Ospedale Policlinico San Martino, Presidio Ospedaliero Santo Spirito, Pescara, Azienda Ospedaliera per l'Emergenza Canizzaro, Azienda Ospedaliera dei Colli, Azienda Ospedaliero, Universitaria Ospedali Riuniti
Leads: Ugo Pastorino

This content was sourced from clinicaltrials.gov