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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
Sponsor:
Collaborators:
Associazione Italiana per la Ricerca sul Cancro
Ministry of Health, Italy
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4099 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   49 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current or former smokers, age ≥50 years or older with a minimum of 20 pack-years smoking history, no history of malignant disease, and adequate performance status (assessed on the basis of the patient's eligibility to undergo thoracic surgery).

Exclusion Criteria:

  • History of malignant disease in the previous years and not adequate performance status (assessed on the basis of the patient's eligibility to undergo thoracic surgery).

Information from the National Library of Medicine

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


Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Associazione Italiana per la Ricerca sul Cancro
Ministry of Health, Italy
Investigators
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Principal Investigator: Ugo Pastorino, MD Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02837809    
Other Study ID Numbers: INT 53/05
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
low-dose computed tomography
lung
randomized controlled trial
neoplasms
screening
smoking
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases