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NCT Number: NCT05486455

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

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.

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Key information

Conditions

Smoking Behavior

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Joseph

Marseille, France

Location status: Recruiting

Location contact

Arnaud Boyer

PRINCIPAL_INVESTIGATOR

Cécile BIELMANN

CONTACT

[email protected]

0033488731070

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low-dose chest CT scan

Diagnostic Test

baseline, 1-year, 3-year and 5-year low-dose CT scan

Primary outcomes

  1. Positive Predictive Value (PPV)

    Time frame: 5 years

Secondary outcomes

  1. Sensitivity

    Time frame: 5 years

  2. Specificity

    Time frame: 5 years

  3. Early stage lung cancer detection rate (stage I and II)

    Time frame: 5 years

  4. 5-year survival rate of patients who have undergone thoracic surgery

    Time frame: 5 years

  5. Rate of smoking-related co-morbidities detected on low-dose CT scan

    Time frame: 5 years

    smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm.

  6. Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)

    Time frame: 5 years

  7. Risk ratio of lung cancer

    Time frame: 5 years

  8. Number of false positive results

    Time frame: 5 years

  9. Penetration rate

    Time frame: 5 years

    number of subjects included / number of includible subjects

  10. Smoking cessation rates

    Time frame: 5 years

  11. EORTC QLQ-C30 score (version 3)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile Bielmann

CONTACT

[email protected]

0033488731070

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2022
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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