Clinical trial · Interventional
Early Lung Cancer Detection in High Risk Individuals
Early Lung Cancer Detection With Spiral Computed Tomography (CT), Positron Emission Tomography (PET) and Biomarkers: Randomized Trial in High Risk Individuals
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Low Dose CT, annual or biennial, associated with primary prevention and pulmonary function test evaluation.
- interventionNames
- Radiation: Low dose CT
- type
- NO_INTERVENTION
- label
- Control
- description
- Program of primary prevention with pulmonary function test evaluation
Primary outcomes (1)
- measure
- Lung cancer mortality
- timeFrame
- 10 years
- description
- evaluate the impact on mortality of early lung cancer detection through LDCT at annual or biennial intervals versus no screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 49 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (23)
- BACKGROUNDSozzi G, Roz L, Conte D, Mariani L, Andriani F, Lo Vullo S, Verri C, Pastorino U. Plasma DNA quantification in lung cancer computed tomography screening: five-year results of a prospective study. Am J Respir Crit Care Med. 2009 Jan 1;179(1):69-74. doi: 10.1164/rccm.200807-1068OC. Epub 2008 Sep 11. PMID 18787214
- BACKGROUNDSozzi G, Pastorino U, Croce CM. MicroRNAs and lung cancer: from markers to targets. Cell Cycle. 2011 Jul 1;10(13):2045-6. doi: 10.4161/cc.10.13.15712. No abstract available. PMID 21623159
- BACKGROUNDBoeri M, Pastorino U, Sozzi G. Role of microRNAs in lung cancer: microRNA signatures in cancer prognosis. Cancer J. 2012 May-Jun;18(3):268-74. doi: 10.1097/PPO.0b013e318258b743. PMID 22647364
- RESULTMarchiano A, Calabro E, Civelli E, Di Tolla G, Frigerio LF, Morosi C, Tafaro F, Ferri E, Sverzellati N, Camerini T, Mariani L, Lo Vullo S, Pastorino U. Pulmonary nodules: volume repeatability at multidetector CT lung cancer screening. Radiology. 2009 Jun;251(3):919-25. doi: 10.1148/radiol.2513081313. Epub 2009 Apr 20. PMID 19380692
- RESULTRoz L, Verri C, Conte D, Miceli R, Mariani L, Calabro' E, Andriani F, Pastorino U, Sozzi G. Plasma DNA levels in spiral CT-detected and clinically detected lung cancer patients: a validation analysis. Lung Cancer. 2009 Nov;66(2):270-1. doi: 10.1016/j.lungcan.2009.08.011. Epub 2009 Sep 9. No abstract available. PMID 19744743
- RESULTSverzellati N, Ingegnoli A, Calabro E, Randi G, La Vecchia C, Marchiano A, Kuhnigk JM, Hansell DM, Zompatori M, Pastorino U. Bronchial diverticula in smokers on thin-section CT. Eur Radiol. 2010 Jan;20(1):88-94. doi: 10.1007/s00330-009-1515-2. Epub 2009 Jul 14. PMID 19597819
- RESULTBoeri M, Verri C, Conte D, Roz L, Modena P, Facchinetti F, Calabro E, Croce CM, Pastorino U, Sozzi G. MicroRNA signatures in tissues and plasma predict development and prognosis of computed tomography detected lung cancer. Proc Natl Acad Sci U S A. 2011 Mar 1;108(9):3713-8. doi: 10.1073/pnas.1100048108. Epub 2011 Feb 7.