Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2027-10-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Procedure

Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules

Group Type OTHER

Low-dose computed tomography of the chest

Intervention Type PROCEDURE

Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules

Interventions

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Low-dose computed tomography of the chest

Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No