Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-dose computed tomography of the chest.
- Who it may be relevant to
- Registry conditions: Lung Cancer Screening. Basic parameters: 50 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Low-dose computed tomography of the chest
Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules
Primary outcome measures
- Performance of trained radiologists for lung cancer screening [Time frame: 2 years]
Secondary outcome measures (10)
- Effectiveness of screening [Time frame: 2 years]
- Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value [Time frame: 2 years]
- Analysis of the performance of a reading by detection software alone [Time frame: 2 years]
- Analysis of the concordances of the different readings [Time frame: 2 years]
- Adherence to screening [Time frame: 2 years]
- Analysis of the impact of screening on smoking cessation [Time frame: 2 years]
- Psychological impact of screening [Time frame: 2 years]
- Number of co-morbidities (COPD, coronary artery disease) detected [Time frame: 2 years]
- Evaluation of costs induced by screening [Time frame: 2 years]
- Prevalence of osteoporosis by opportunistic screening [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Hôtel-Dieu — Paris
Publications
- Revel MP, Abdoul H, Chassagnon G, Canniff E, Durand-Zaleski I, Wislez M. Lung CAncer SCreening in French women using low-dose CT and Artificial intelligence for DEtection: the CASCADE study protocol. BMJ Open. 2022 Dec 8;12(12):e067263. doi: 10.1136/bmjopen-2022-067263. PMID 36600392
Identifiers
NCT: NCT05195385 · APHP210362 · 2021-A02265-36