Lung cancer Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Age-appropriate men will be identified from a population list serviced by medical institutions participating in the project. Identified participants with respond to a pre-selection questionnaire sent
Sponsors
N.N. Alexandrov National Cancer Centre
International Agency For Research On Cancer
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Availability of written informed consent 2. Age from 50 through 70 years 3. Risk-based approach a 5-year lung cancer risk of at least 1.51% (using the Lung Cancer Risk Assessment Tool) 4. No advanced chronic lung diseases 5. No advanced occupational hazard conditions 6. A clinical-functional status allowing the possibility to administer surgical treatment
Exclusion criteria
Exclusion criteria: 1. Second primaries of synchronous and metachronous cancer of both lungs or a combination of lung cancer with cancer of other organs excluding uterine cervix cancer, non-melanoma skin cancer, and lower lip cancer radically treated at least 3 years ago 2. Previous special treatment for lung cancer 3. Acute tuberculosis 4. Myocardial infarction, stroke in the case history in the course the past 6 months before enrolling in the study Criteria for excluding from the study, based on examination findings: 1. Congestive heart failure, class III or IV according to NYHA (New York Heart Association) classification, unrelated to the neoplastic process 2. Uncontrolled severe hypertension or hypertension with systolic pressure >180 mm Hg and/or diastolic pressure >110 mm Hg, or orthostatic hypotension 3. A positive test for human immunodeficiency virus (HIV), B or C hepatitis, or lues 4. Mental diseases 5. Chronic alcohol addiction 6. Surd mutism Administrative causes for exclusion from the study: 1. Kinship relations between the patient and the Centre’s employers 2. The inability of visits/procedure performance and regular medical check-up 3. Refusal to undergo examination or treatment in the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The clinical-stage distribution of lung cancer using low-dose CT scan at a single time point 2. Number of cases eligible for radical surgical procedure measured using clinical and radiological evaluation over the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of invited individuals selected for LDCT screening according to the proposed risk-based approach, measured by the pre-selection questionnaire responses throughout the study 2. Radiological findings of the LDCT: number of participants with nodules, the characteristic of the nodules and accuracy of the radiological findings with the pathology report (for participants undergoing biopsy) measured at a single time point 3. Concordance of radiological findings among the radiologists involved in the project, by Cohen's kappa coefficient analysis measured throughout the study 3. Document and monitor the harms of the LDCT screening, recorded in the study questionnaires and medical records, throughout the study | — |
Countries
Belarus
Contacts
Public ContactOlga Trusova
Outcome results
None listed