Trial Title:
Lung Cancer Prevention Screening Programme in Italy
NCT ID:
NCT05766046
Condition:
Lung Cancer
COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
Cardiovascular Diseases
Conditions: Official terms:
Respiratory Tract Infections
Lung Neoplasms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Conditions: Keywords:
lung cancer
LDCT
cytisine
screening
smoking cessation
DOPC
cardiovascular diseases
primary prevention
secondary prevention
RCT
microRNA
biomarkers
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
early lung cancer detection
Description:
standard treatment for early lung cancer detection with LDCT at one or two years interval
Arm group label:
Risk-based arm
Arm group label:
Standard arm
Intervention type:
Other
Intervention name:
blood test
Description:
blood analysis for microRNA and other biomarkers detection
Arm group label:
Risk-based arm
Arm group label:
Standard arm
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.
Detailed description:
Tobacco smoking is the most relevant cause of avoidable death in all high-income
countries, including the European Union and Italy. Smoking increases the risk of dying
from emphysema by 10 times, doubles that of having a stroke, and increases two to four
times that of being affected by a heart attack. In addition, the carcinogenic substances
contained in tobacco smoke are responsible for about 90% of lung cancers, but also for
most cancers of the oral cavity, larynx and bladder. Therefore, the main causes of death
attributable to tobacco smoke are cancers, cardiovascular and respiratory diseases. Lung
cancer is a serious and far-reaching health problem with reduced survival after 5 years.
Seventy per cent of lung cancers are at an advanced clinical stage and difficult to treat
when the first symptoms occur, and a certain diagnosis is made. Lung cancer mainly
affects people over the age of 50, with a peak incidence around 70-75 years. Over a third
of deaths attributed to smoking are between 35 and 69 years of age. For long time it was
not possible to have a certain diagnosis by diagnostic tests. Only at the end of the
'90s, it became clear that computed tomography allows lung cancer to be detected at an
early stage (stage I), before symptoms occur.
Large-scale randomized clinical trials (RCTs) have shown that early detection of lung
cancer by CT can reduce lung cancer mortality between 20% and 39%, according to the
duration of the intervention. In particular, LDCT screening has been shown to
significantly reduce lung cancer mortality by 8-26% for men and 26-61% in women.
International lung cancer screening guidelines, currently adopted in the United States,
recommend repeating LDCT at annual intervals. However, annual chest LDCT screening has
heavy economic impact and can induce radiation-related damage.
Recent studies have shown that the first LDCT screening exam provides information on
individual risk thus allowing the personalization of the screening interval. In
particular, there are indications that screening interval can be extended safely for
low-risk individuals. For example, several studies show that individuals with a negative
baseline exam have a substantially lower risk than those with a positive baseline exam. A
randomized prospective assessment of risk-based screening intervals therefore has the
potential to improve efficiency and reduce the economic-health impact of lung cancer
screening. In fact, a personalized screening protocol has a less serious economic impact,
both at the instrumental level and in terms of the commitment of the radiological staff.
In this context, the RISP network aims to promote a nationwide early diagnosis program
with LDCT that reduces mortality from lung cancer, and at the same time, brings benefit
in primary prevention of smoking-related diseases, such as chronic obstructive pulmonary
diseases (COPD) and other cardiovascular diseases. RISP will start lung screening in a
gradual and controlled way, through a network of reference centers with multidisciplinary
clinical competence that provide adequate coverage of the territory, and meanwhile a
level of quality fitting to the standards currently achieved in the screening of other
cancers (breast, cervix, colon). A systematic screening program will also increase the
percentage of lung cancer patients eligible for early-stage surgical resection from the
current 25% (without screening) to 50-60%.
At baseline- each volunteer will undergo:
- a baseline questionnaire (e.g. socio-demographic, smoking habits, etc) with
anti-smoking counseling program that includes cytisine-based anti-smoking therapy.
- blood sampling for the assessment of the inflammatory and metabolic profile (i.e.
bio-markers) (optional)
- evaluation of respiratory function and measurement of carbon monoxide (CO)
- chest LDCT without contrast
- anthropometric evaluation (e.g. weight, height, BMI, etc)
Follow-up- each randomized volunteer will undergo:
- clinical examinations of LDCT
- blood sampling and CO after 12 months of follow-up or 24 months depending on the arm
to which they belong.
Imaging will be performed by volumetric acquisition with a computed tomography scanner
equipped with advanced technology hardware and software, including an AI-based second
reading that will be validated by a radiologists panel.
All data will be entered into a password-protected database. The protection of the
identity of the subjects will be guaranteed by assigning unique participation numbers
specific to the study. In a separate database, accessible only by the principal
investigator or assigned team members, the unique identification number can be linked to
participants' names and addresses for the purposes of local and central administrative
processes such as scheduling scans, sending invitation letters, sending screening results
and questionnaires for topics, and collecting follow-up information. All volunteer
samples and paper/electronic files will be destroyed 15 years after completion of the
study.
Participants are assured that no personal data will be published in articles, reports or
other study documentation.
Randomization will be carried out using real-time automated statistical software:
eligible subjects will be randomly assigned to one of the two intervention arms (A, B)
with a 1:1 ratio.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
55 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Chiara Bovolenta
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Chiara Bovolenta, PhD
Phone:
0223903928
Email:
chiara.bovolenta@istitutotumori.mi.it
Investigator:
Last name:
Ugo Pastorino, MD
Email:
Principal Investigator
Start date:
September 17, 2022
Completion date:
September 2026
Lead sponsor:
Agency:
Ugo Pastorino
Agency class:
Other
Collaborator:
Agency:
Presidio Ospedaliero Santo Spirito, Pescara
Agency class:
Other
Collaborator:
Agency:
IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera Pugliese Ciaccio
Agency class:
Other
Collaborator:
Agency:
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera dei Colli
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero-Universitaria di Parma
Agency class:
Other
Collaborator:
Agency:
IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia, Reggio Emilia
Agency class:
Other
Collaborator:
Agency:
Istituto Nazionale dei Tumori Regina Elena, Roma
Agency class:
Other
Collaborator:
Agency:
Ospedale Policlinico San Martino
Agency class:
Other
Collaborator:
Agency:
A.O. Ospedale Papa Giovanni XXIII
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Agency class:
Other
Collaborator:
Agency:
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
Agency class:
Other
Collaborator:
Agency:
San Luigi Gonzaga Hospital
Agency class:
Other
Collaborator:
Agency:
Istituto Tumori Giovanni Paolo II, BARI
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera per l'Emergenza Canizzaro
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero-Universitaria Careggi
Agency class:
Other
Collaborator:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766046
https://cordis.europa.eu/project/id/848294
https://www.ncbi.nlm.nih.gov/books/NBK568586/pdf/Bookshelf_NBK568586.pdf
