Clinical trial · Observational
Continuous Observation of Smoking Subject
Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population
NCT01248806CI-TRIAL-00058489COSMOScompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.
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 |
|---|---|---|---|
| Subjects at High Risk of Lung Cancer Due to Smoking | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose CT scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Smokers or former smokers, Aged ≥ 50
- description
- Men and women current daily smokers or former smokers, Aged ≥ 50
- interventionNames
- Radiation: Low dose CT scan
Primary outcomes (2)
- measure
- To determine the prevalence of malignant pulmonary disease at the first CT examination
- timeFrame
- once after enrollment
- description
- CT scan
- measure
- To assess the radiological detection of disease during the 10 year follow-up
- timeFrame
- once per year for a 10 year follow-up period
- description
- CT scan
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 50 * Current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by multiplying the number of packs per day by the total number of years smoked) * Former smoker should have stopped smoking within the 10 years before the inclusion in the study protocol Exclusion Criteria: * Not currently suffering from malignant disease or having had malignant disease within the last 5 years * Not having known pulmonary pathology * Not having performed a chest CT scan during the last 2 years
References
Publications (3)
- RESULTVeronesi G, Bellomi M, Mulshine JL, Pelosi G, Scanagatta P, Paganelli G, Maisonneuve P, Preda L, Leo F, Bertolotti R, Solli P, Spaggiari L. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4. PMID 18308420
- RESULTPelosi G, Sonzogni A, Veronesi G, De Camilli E, Maisonneuve P, Spaggiari L, Manzotti M, Masullo M, Taliento G, Fumagalli C, Bellomi M, Travis WD, Kadivar M, Viale G. Pathologic and molecular features of screening low-dose computed tomography (LDCT)-detected lung cancer: a baseline and 2-year repeat study. Lung Cancer. 2008 Nov;62(2):202-14. doi: 10.1016/j.lungcan.2008.03.012. Epub 2008 May 2. PMID 18450320
- RESULTVeronesi G, Bellomi M, Veronesi U, Paganelli G, Maisonneuve P, Scanagatta P, Leo F, Pelosi G, Travaini L, Rampinelli C, Trifiro G, Sonzogni A, Spaggiari L. Role of positron emission tomography scanning in the management of lung nodules detected at baseline computed tomography screening. Ann Thorac Surg. 2007 Sep;84(3):959-65; discussion 965-6. doi: 10.1016/j.athoracsur.2007.04.058. PMID 17720408