NCT04315766|Unknown
Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention
SMAC-1
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SMAC-1
Sponsor study identifier
observational
2,000
1 country
1
Study Start
October 10, 2018
Actual (reported)Primary Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2018
Actual (reported)January 10, 2019
Actual (reported)March 20, 2020
Actual (reported)October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Validation of circulating markers to enhance LDCT sensitivity and specificity of the screening for lung cancer, CVD and COPD early detection.
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.
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
First Submitted
January 10, 2019
First Posted
March 20, 2020
Study Start
October 10, 2018
Actual (reported)Primary Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy
from 10 Oct 2018 to 10 Oct 2021
Cost benefit analysis of LC screening program
from 10 Oct 2018 to 10 Oct 2021
Contact the study team to confirm eligibility.
Study Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 20, 2020
Record last verified: 2020-03
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