Project Lung Cancer Screening in Southern Denmark

NCT06537804 | Active Not Recruiting

• 1 other identifier: S-20240033
• Study Type: interventional
• Target: 1,332
• Locations: 1 country
• Sites: 2

Brief Summary

One thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. The participants will be identified through an initial questionnaire survey concerning smoking history and general health. Project participants are offered a low-dose CT (LDCT) scan annually for three consecutive years. In relation to the first scan, a lung function test will also be performed. The screening process will be evaluated for possible national implementation of a lung cancer screening program in Denmark.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold

  ratio

  Up to 36 months

Secondary Outcomes (19)

• Characteristics of citizens from the cohort based on registry data

  Up to 36 months

• Participation rate

  36 months (complete study period)

• Dropouts

  36 months (complete study period)

• Lung cancer found on low dose CT-scans

  Baseline, after 1 year, after 2 years

• Inconclusive or non-malignant findings on low dose CT scans

  Baseline, after 1 year, after 2 years

Study Arms (2)

Intervention

OTHER

Low-dose CT scans are performed once a year from 2024 to 2026 to screen for lung cancer including a lung function test the first year of attendance (2024).

Radiation: Screening by low-dose CT scan

Control

NO INTERVENTION

Citizens from the cohort who are randomized to no intervention.

Interventions

Screening by low-dose CT scan RADIATION

Screening for lung cancer by low-dose CT scan

Intervention

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heavy smokers (≥ 30 pack years) or citizens with a PLCOm2012 calculated 6-year risk of lung cancer \> 2%.
• Age: 60-74 years old
• Residence on Funen and surrounding islands

You may not qualify if:

• Cancer treatment or follow-up (except non melanoma skin cancer and similar low malignant cancers) within the past 12 months
• CT scan performed within the past 12 months

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (2)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Department of Radiology, Svendborg Hospital

Svendborg, Region Syddanmark, 5700, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Stenger, Consultant

  Odense University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: August 5, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)