Clinical trial NCT05195385: Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
Official title: Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer Screening
Keywords: lung neoplasms
multidetector computed tomography
early detection of cancer
artificial intelligence
lung cancer screening
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministère de la Santé et des Solidarités
name: National Cancer Institute, France
First posted: 2022-01-19
Enrollment: 2635
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts.

The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.

Detailed description: Lung cancer is the leading cause of cancer death, worldwide. Several randomized studies have demonstrated that annual or biennial low-dose CT screening reduces lung cancer mortality. However, these studies involved expert chest radiologists, with double reading being performed in most studies. Furthermore, none of the published studies have evaluated the role of artificial intelligence to serve as second of concurrent reader.

Women with at least 20 pack-year smoking history who quitted smoking less than 15 years ago will be enrolled to have baseline, 1-year and 2-year low-dose CT of the chest.

The CT scans will be read on site by a general radiologist trained to lung cancer screening according to the European lung cancer screening certification program, first without then with the aid of an artificial algorithm trained to lung nodule detection (Veye Chest, Aidence). All CT scans will also be read by 2 chest experts, who will resolve their disagreement by a consensus reading if necessary. Patient management will rely on the double reading by expert. The criteria for positive screen result are as follows: solid nodule \> 500 mm3 (10 mm) or growing (30% volume increase), part-solid nodule with \> 8 mm solid component or new or growing, pure ground glass nodule developing a solid portion.

Eligibility criteria: Inclusion Criteria:

* Women aged from 50 to 74 years
* who had smoked at least 20 pack years and quit less than 15 years ago
* Had given their consent and accepted the need for a 2-year follow-up
* Affiliated to the social security system

Exclusion Criteria

* Presence of clinical symptoms suggesting malignancy (weight loss, hemoptysis) or ongoing infection (cough with fever)
* Evolving cancer
* History of lung cancer
* A 2-year follow-up not possible
* Chest CT scan performed within 2 years prior to inclusion

Primary outcomes:
measure: Performance of trained radiologists for lung cancer screening
timeFrame: 2 years
Secondary outcomes:
measure: Effectiveness of screening
timeFrame: 2 years
measure: Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value
timeFrame: 2 years
measure: Analysis of the performance of a reading by detection software alone
timeFrame: 2 years
measure: Analysis of the concordances of the different readings
timeFrame: 2 years
measure: Adherence to screening
timeFrame: 2 years
measure: Analysis of the impact of screening on smoking cessation
timeFrame: 2 years
measure: Psychological impact of screening
timeFrame: 2 years
measure: Number of co-morbidities (COPD, coronary artery disease) detected
timeFrame: 2 years
measure: Evaluation of costs induced by screening
timeFrame: 2 years
measure: Prevalence of osteoporosis by opportunistic screening
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôtel-Dieu
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-Pierre REVEL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie WISLEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: