Early Lung Cancer Detection in High Risk Individuals (MILD)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|