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Recruiting NCT05486455

Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers

No phase Interventional Smoking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose chest CT scan.
Who it may be relevant to
Registry conditions: Smoking. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers: a "Real Life" Study

Overview

Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.

Interventions

  • Diagnostic test Low-dose chest CT scan
    baseline, 1-year, 3-year and 5-year low-dose CT scan

Primary outcome measures

  • Positive Predictive Value (PPV) [Time frame: 5 years]
Secondary outcome measures (11)
  • Sensitivity [Time frame: 5 years]
  • Specificity [Time frame: 5 years]
  • Early stage lung cancer detection rate (stage I and II) [Time frame: 5 years]
  • 5-year survival rate of patients who have undergone thoracic surgery [Time frame: 5 years]
  • Rate of smoking-related co-morbidities detected on low-dose CT scan [Time frame: 5 years]
  • Rate of additional examinations (including invasive diagnostic tests and surgery with benign results) [Time frame: 5 years]
  • Risk ratio of lung cancer [Time frame: 5 years]
  • Number of false positive results [Time frame: 5 years]
  • Penetration rate [Time frame: 5 years]
  • Smoking cessation rates [Time frame: 5 years]
  • EORTC QLQ-C30 score (version 3) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Male or female 50-80 years old
  • Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)

Exclusion criteria

  • Recent history of chest CT scan (within 12 months)
  • Person unable to climb 2 floors
  • Weight > 140kg
  • Personal history of cancer < 5 years (currently being monitored by thoracic imaging)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Saint Joseph — Marseille

Identifiers

NCT: NCT05486455 · DEPITAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗