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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Screening
• Intervention / Treatment: Procedure: Low-dose computed tomography of the chest

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.

• Study Type: Interventional
• Enrollment (Estimated): 2635
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Pierre REVEL, PhD; Phone Number: +33 1 42 34 79 10; Email: marie-pierre.revel@aphp.fr
• Study Contact Backup: Name: Adèle BELLINO, MS; Phone Number: +33 1 58 41 11 95; Email: adele.bellino@aphp.fr

Study Locations

• France
  • Paris, France, 75004
    • Recruiting
    • Hôtel-Dieu
    • Contact: Marie-Pierre REVEL, PhD; Phone Number: +33 1 42 34 79 10; Email: marie-pierre.revel@aphp.fr
    • Contact: Marie WISLEZ, PhD; Phone Number: +33 1 58 41 19 06; Email: marie.wislez@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Procedure; Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of trained radiologists for lung cancer screening	Sensitivity, specificity, predictive values compared to double reading by experts	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of screening	Proportion of participants with a positive screening test and proportion of confirmed diagnosis of cancer	2 years
Analysis of the concordances of the different readings	Kappa concordance coefficient between the different readings	2 years
Analysis of the impact of screening on smoking cessation	Smoking cessation rate at the end of the study	2 years
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
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
Evaluation of costs induced by screening	Cost measures: total cost of screening, average cost per woman, average cost per woman screened	2 years
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: National Cancer Institute, France; Ministère de la Santé et des Solidarités
• Investigators: Principal Investigator: Marie-Pierre REVEL, PhD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Marie WISLEZ, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Estimated): October 8, 2027
• Study Completion (Estimated): October 8, 2027

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: artificial intelligence; lung neoplasms; lung cancer screening; early detection of cancer; multidetector computed tomography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: APHP210362; 2021-A02265-36 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No