Early Lung Cancer Detection in High Risk Individuals (MILD)
|ClinicalTrials.gov Identifier: NCT02837809|
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : May 11, 2017
The MILD project is a randomized lung cancer screening trial whose primary aim is to evaluate the impact on mortality of early lung cancer detection through LDCT (low-dose computed tomography) in 2 groups: a control group undergoing a program of primary prevention with pulmonary function test evaluation and a group undergoing a periodic spiral CT associated with primary prevention and pulmonary function test evaluation. This last one is also randomized in two arms: yearly low-dose CT vs CT every 2 years.
MILD trial comprehensive design combines for the first time primary prevention (smoking cessation) with early detection, and molecular risk profile through assessing the value of blood and tissue biomarkers.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Low dose CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4099 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Lung Cancer Detection With Spiral Computed Tomography (CT), Positron Emission Tomography (PET) and Biomarkers: Randomized Trial in High Risk Individuals|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||October 2016|
Low Dose CT, annual or biennial, associated with primary prevention and pulmonary function test evaluation.
Radiation: Low dose CT
annual CT vs biennial CT
Other Name: LDCT
No Intervention: Control
Program of primary prevention with pulmonary function test evaluation
- Lung cancer mortality [ Time Frame: 10 years ]evaluate the impact on mortality of early lung cancer detection through LDCT at annual or biennial intervals versus no screening
- Smoking cessation [ Time Frame: 10 years ]evaluate the impact on smoking cessation of early lung cancer detection through LDCT at annual or biennial intervals versus no screening
- Molecular risk profile through assessing the value of circulating DNA in blood samples [ Time Frame: 10 years ]Circulating DNA, quantified through a real-time quantitative PCR approach based on the 5' nucleotide method: Correlation of results of qPCR DNA levels, epidemiological data on smoking exposition and level of functional impairment (spirometry and DLCO) to define a map of individual biological damage and define a quantitative score of individual risk of lung cancer, possibly related to preneoplastic lung lesions.
- Molecular risk profile through assessing the value of microRNA in blood and tissue samples [ Time Frame: 10 years ]MicroRNA expression profile, using TaqMan microfluidic cards: Association with aggressiveness of the disease and poor survival in tumors and in normal lung tissue and the critical influence of a smoking related lung microenvironment on tumor progression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837809
|Fondazione IRCCS Istituto Nazionale dei Tumori|
|Milan, Italy, 20133|
|Principal Investigator:||Ugo Pastorino, MD||Fondazione IRCCS Istituto Nazionale dei Tumori di Milano|