Clinical trial NCT04315766: Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention
Official title: Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Cardiovascular Disease (CVD)
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Cancer risk prevention
Cancer risk reduction
Cardiovascluar disease prevention
microRNAs
COPD prevention
Lung cancer circulating biomarkers
Lung cancer screening
Minimally invasive surgery
Low Dose Computed Tomography (LDCT)
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Ospedale San Raffaele
First posted: 2020-03-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population should have the following inclusion criteria:

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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To implement the screening program combining lung cancer, CVD and COPD prevention
timeFrame: from 10 Oct 2018 to 10 Oct 2021
Secondary outcomes:
measure: Validation of circulating markers to enhance LDCT sensitivity and specificity of the screening for lung cancer, CVD and COPD early detection.
timeFrame: from 10 Oct 2018 to 10 Oct 2021
measure: Cost benefit analysis of LC screening program
timeFrame: from 10 Oct 2018 to 10 Oct 2021
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References: