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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486455
• Other study ID #: DEPITAB
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: October 2028

Study information

• Verified date: December 2022
• Source: Hospital St. Joseph, Marseille, France
• Contact: Cecile Bielmann
• Phone: 0033488731070
• Email: cbielman[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Predictive Value (PPV)		5 years
Secondary	Sensitivity		5 years
Secondary	Specificity		5 years
Secondary	Early stage lung cancer detection rate (stage I and II)		5 years
Secondary	5-year survival rate of patients who have undergone thoracic surgery		5 years
Secondary	Rate of smoking-related co-morbidities detected on low-dose CT scan	smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm.	5 years
Secondary	Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)		5 years
Secondary	Risk ratio of lung cancer		5 years
Secondary	Number of false positive results		5 years
Secondary	Penetration rate	number of subjects included / number of includible subjects	5 years
Secondary	Smoking cessation rates		5 years
Secondary	EORTC QLQ-C30 score (version 3)	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.	5 years