Pilot programme for lung cancer screening in Belarus

Not Applicable

• Conditions: ung cancer; Cancer; Malignant neoplasm of bronchus and lung

• Registration Number: ISRCTN16878075
• Lead Sponsor: .N. Alexandrov National Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-04
• Last Update Posted: 14 September 2020
• Study Completion: 2024-12-02

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 3000

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The clinical-stage distribution of lung cancer using low-dose CT scan at a single time point<br> 2. Number of cases eligible for radical surgical procedure measured using clinical and radiological evaluation over the duration of the study<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 3. Concordance of radiological findings among the radiologists involved in the project, by Cohen's kappa coefficient analysis measured throughout the study<br> 3. Document and monitor the harms of the LDCT screening, recorded in the study questionnaires and medical records, throughout the study<br>