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

Lung Cancer Screening Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195385
• Other study ID #: APHP210362
• Secondary ID: 2021-A02265-36
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: October 8, 2027

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie-Pierre REVEL, PhD
• Phone: +33 1 42 34 79 10
• Email: marie-pierre.revel[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2635
• Est. completion date: October 8, 2027
• Est. primary completion date: October 8, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Screening
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Hôtel-Dieu	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministère de la Santé et des Solidarités, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of trained radiologists for lung cancer screening	Sensitivity, specificity, predictive values compared to double reading by experts	2 years
Secondary	Effectiveness of screening	Proportion of participants with a positive screening test and proportion of confirmed diagnosis of cancer	2 years
Secondary	Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value	For the general population and for the COPD population. Sensitivity, specificity, predictive values and likelihood ratios of the initial reading compared to the expert readings, using histological diagnosis as gold standard for positive screens and stability at 2 years for negative screens	2 years
Secondary	Analysis of the performance of a reading by detection software alone	For the general population and for the COPD population. Sensitivity, specificity, predictive values and likelihood ratios of artificial intelligence alone	2 years
Secondary	Analysis of the concordances of the different readings	Kappa concordance coefficient between the different readings	2 years
Secondary	Adherence to screening	Number of participants related to the number of eligible women, having completed all the required scans (3 to 6), speed of inclusion in the study. Enrolment will be assessed on the basis of the following characteristics: weaned or non-weaned smokers, level of education, socio-economic category, etc	2 years
Secondary	Analysis of the impact of screening on smoking cessation	Smoking cessation rate at the end of the study	2 years
Secondary	Psychological impact of screening	HADS (Hospital Anxiety and Depression Scale) questionnaire at each scan, Cancer worry scale, Satisfaction with Decision scale at inclusion and end of study, all translated into French	2 years
Secondary	Number of co-morbidities (COPD, coronary artery disease) detected	Number of participants related to the number of women included in the study for whom treatment is initiated (bronchodilators/ statins or revascularization/ osteoporosis treatment)	2 years
Secondary	Evaluation of costs induced by screening	Cost measures: total cost of screening, average cost per woman, average cost per woman screened	2 years
Secondary	Prevalence of osteoporosis by opportunistic screening	Presence of at least one thoracic vertebral fracture and measurement of trabecular attenuation of the T8 vertebral body	2 years