Lung cancer Cancer
Conditions
Interventions
Age-appropriate men and women will be identified from a population list serviced by medical institutions participating in the project. Identified participants will respond to a pre-selection questionn
Sponsors
National Cancer Control Programme (PRONACCAN) of Uruguay
International Agency For Research On Cancer
Eligibility
Sex/Gender
All
Age
50 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Availability of written informed consent 2. Aged 50 to 74 years 3. 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 treatment for lung cancer 3. Acute tuberculosis 4. Myocardial infarction, stroke in the case history in the course of 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 New York Heart Association (NYHA) classification, unrelated to the neoplastic process 2. Uncontrolled severe hypertension or hypertension with systolic pressure >180 mmHg and/or diastolic pressure >110 mmHg, 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-ups 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 with low-dose computed tomography (CT) scan using TNM classification at 12, 24, 48 and 60 months 2. Number of cases eligible for radical surgical procedure measured using clinical and radiological evaluation at 12, 24, 48 and 60 months 3. Cost-effectiveness analysis at 60 months. The modelling methodology will allow the researchers to scale costs and outcomes appropriately to the national level using consistent methods. In addition, without estimates of the long-term impact from mathematical modelling, the analysis could be misleading to decision-makers by focusing only on the short-term impact of screening. Aim 1: To align the health economic modelling with the contents of the Statistical Analysis Plan (SAP). The SAP objectives to estimate the number of scans per cancer detected and to estimate the short-term impact of screening on early cancer detection and lung cancer mortality will tie in with Objective 1. Objective 1: Estimate the cost per cancer detected within a potential national lung cancer screening programme in the short term. Aim 2: Use modelling methodology to predict the cost-effectiveness, long-term budget impact and return-on-investment of a potential national lung cancer screening programme. Objective 2: Predict the long-term clinical impact of screening within a potential national lung cancer screening programme. Objective 3: Predict the long-term budget impact and return-on-investment of a potential national lung cancer screening programme. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of invited individuals selected for low-dose computed tomography (LDCT) screening according to the proposed risk-based approach, measured by the pre-selection questionnaire responses at 12, 24 and 36 months 2. Radiological findings of the LDCT: the number of participants with nodules, the characteristics of the nodules and the accuracy of the radiological findings with the pathology report (for participants undergoing biopsy) measured at 12, 24, 48 and 60 months 3. The harms of the LDCT screening, recorded in study questionnaires and medical records at 12, 24, 48 and 60 months | — |
Countries
Uruguay
Contacts
Public ContactVirginia;Pablo Rodriguez Sande;Palacio
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Outcome results
None listed