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NCT Number: NCT05195385

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

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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Key information

Age range

50 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose computed tomography of the chest

Procedure

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

Primary outcomes

  1. Performance of trained radiologists for lung cancer screening

    Time frame: 2 years

    Sensitivity, specificity, predictive values compared to double reading by experts

Secondary outcomes

  1. Effectiveness of screening

    Time frame: 2 years

    Proportion of participants with a positive screening test and proportion of confirmed diagnosis of cancer

  2. Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value

    Time frame: 2 years

    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

  3. Analysis of the performance of a reading by detection software alone

    Time frame: 2 years

    For the general population and for the COPD population. Sensitivity, specificity, predictive values and likelihood ratios of artificial intelligence alone

  4. Analysis of the concordances of the different readings

    Time frame: 2 years

    Kappa concordance coefficient between the different readings

  5. Adherence to screening

    Time frame: 2 years

    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

  6. Analysis of the impact of screening on smoking cessation

    Time frame: 2 years

    Smoking cessation rate at the end of the study

  7. Psychological impact of screening

    Time frame: 2 years

    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

  8. Number of co-morbidities (COPD, coronary artery disease) detected

    Time frame: 2 years

    Number of participants related to the number of women included in the study for whom treatment is initiated (bronchodilators/ statins or revascularization/ osteoporosis treatment)

  9. Evaluation of costs induced by screening

    Time frame: 2 years

    Cost measures: total cost of screening, average cost per woman, average cost per woman screened

  10. Prevalence of osteoporosis by opportunistic screening

    Time frame: 2 years

    Presence of at least one thoracic vertebral fracture and measurement of trabecular attenuation of the T8 vertebral body

Study contacts

Contact information is provided by the study sponsor or research team.

Adèle BELLINO, MS

CONTACT

[email protected]

+33 1 58 41 11 95

Marie-Pierre REVEL, PhD

CONTACT

[email protected]

+33 1 42 34 79 10

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministère de la Santé et des Solidarités
  • National Cancer Institute, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: CASCADE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 19, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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