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

Not Applicable

Recruiting

• Conditions: Smoking
• Interventions: Diagnostic Test: Low-dose chest CT scan

• Registration Number: NCT05486455
• Lead Sponsor: Hospital St. Joseph, Marseille, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Study Start: 2022-11-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT scan	Low-dose chest CT scan	-

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV)	5 years

Secondary Outcome Measures

Name	Time	Method
Penetration rate	5 years	number of subjects included / number of includible subjects
5-year survival rate of patients who have undergone thoracic surgery	5 years
Risk ratio of lung cancer	5 years
Early stage lung cancer detection rate (stage I and II)	5 years
Number of false positive results	5 years
Specificity	5 years
Sensitivity	5 years
Rate of smoking-related co-morbidities detected on low-dose CT scan	5 years	smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm.
Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)	5 years
Smoking cessation rates	5 years
EORTC QLQ-C30 score (version 3)	5 years	The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions.; The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting). In addition, several single item symptom measures are used.; For the five functioning scales and the global quality of life scale, a higher score represents a better level of functioning. For the symptom scales and items, a high score corresponds to a higher level of symptomatology.

Trial Locations

Locations (1)

Hôpital Saint Joseph; 🇫🇷 Marseille, France