Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention

Lung Cancer Clinical Trial

— SMAC-1  

Official title:

Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04315766
• Other study ID #: 2123
• Status: Recruiting
• Start date: October 10, 2018
• Est. completion date: October 2021

Study information

• Verified date: March 2020
• Source: Istituto Clinico Humanitas
• Contact: Giulia Veronesi, MD
• Phone: 02 26435278
• Email: veronesi.giulia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.

The project also includes a cost-effectiveness assessment to validate the feasibility of the program.

Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age = 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (= 2%).

• Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.

• Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.

Exclusion Criteria:

• Previous diagnosis of lung cancer.

• Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).

• Performing a chest CT scan in the last 18 months.

• Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.

Related Conditions & MeSH terms

• Cardiovascular Disease (CVD)
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Cancer
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To implement the screening program combining lung cancer, CVD and COPD prevention	Subjects with increased risk for lung cancer, selected through an epidemiological questionnaire, sign the informed consent and their blood is collected. They then undergo LDCT and an interview at the anti-smoking center. CTs presenting with at least one non-calcified nodule are managed according to dedicated diagnostic algorithm. Nodules indicative of lung cancer will be studied with preoperative diagnosis, with surgical resection preferably performed with a minimally invasive approach. Multimodality treatment is indicated in advanced stage of disease. Subjects with normal findings are scheduled for annuals CT scan for two additional years. Cardiovascular risk will be assessed with the use of the atherosclerotic cardiovascular disease (ASCVD) score, recommended by the American College of Cardiology/American Heart Association, integrated with Reynold risk score and CAC score. The CAC score, calculated on LDCT, is used to quantify the presence of calcium through the coronary system.	from 10 Oct 2018 to 10 Oct 2021
Secondary	Validation of circulating markers to enhance LDCT sensitivity and specificity of the screening for lung cancer, CVD and COPD early detection.	Ten ml of blood is collected before LDCT, for plasma and white blood cells. For lung cancer patients, blood is collected before treatment, at 1-6-12 months after treatment, to analyse markers for minimal residual disease or early recurrence.; We will perform: CTC identification and genomic analysis. Patients are considered CTCs positive based on cytopathology of the isolated cells and detection of characteristic malignant features.; Evaluation of Serum of PTX3, measured with an original sandwich enzyme-linked immunosorbent assay (ELISA); Circulating microRNA profiling. A custom panel of 6 specific microRNAs identified in a previous study on Karolinska cohort and correlating with increase/reduction risk of CVD Mayor adverse cardiovascular events MACE will be tested in 2000 patients.; IL-2, IL-8, CRP, IL-5 and Eosinophils analyses. Interleukin-2 and-8, C-reactive protein, interleukiine-5 and eosinophils concentrations in blood are measured with ELISA kits.	from 10 Oct 2018 to 10 Oct 2021
Secondary	Cost benefit analysis of LC screening program	Cost-benefit analysis of the prevention program. Direct and indirect costs associated with diagnosis and treatment of smoking-related diseases will be compared to those of a control group with disease detected after the appearance of pulmonary symptoms. The incremental cost effectiveness ratio will be evaluated in terms of QUALYS (quality of life adjusted years saved).	from 10 Oct 2018 to 10 Oct 2021