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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Diagnostic test: Low-dose chest CT scan

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecile Bielmann; Phone Number: 0033488731070; Email: cbielman@hopital-saint-joseph.fr

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hopital Saint Joseph
    • Principal Investigator: Arnaud Boyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT scan	Diagnostic test: Low-dose chest CT scan; baseline, 1-year, 3-year and 5-year low-dose CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive Predictive Value (PPV)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity		5 years
Specificity		5 years
Early stage lung cancer detection rate (stage I and II)		5 years
5-year survival rate of patients who have undergone thoracic surgery		5 years
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
Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)		5 years
Risk ratio of lung cancer		5 years
Number of false positive results		5 years
Penetration rate	number of subjects included / number of includible subjects	5 years
Smoking cessation rates		5 years
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

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Investigators: Principal Investigator: Arnaud Boyer, MD, Hôpital Saint Joseph Marseille; Study Director: Illies Bouabdallah, MD, Hôpital Saint Joseph Marseille

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Anticipated): October 1, 2028
• Study Completion (Anticipated): October 1, 2028

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DEPITAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No