Lung Cancer ScreeningCASCADENCT05195385
Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
A study testing Low-dose computed tomography of the chest in people with Lung Cancer Screening, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women only
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Low-dose computed tomography of the chest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,635 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2022to 8 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôtel-Dieu
Paris, 75004
Marie-Pierre REVEL, PhD, +33 1 42 34 79 10, marie-pierre.revel@aphp.fr
Marie WISLEZ, PhD, +33 1 58 41 19 06, marie.wislez@aphp.fr
About this 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.
Read the 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.
- Conditions
- Lung Cancer Screening
- Being tested
- Low-dose computed tomography of the chest
- Keywords
- lung neoplasms, multidetector computed tomography, early detection of cancer, artificial intelligence, lung cancer screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomography of the chestProcedure or surgery
Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules
| Study group | Role | What they receive |
|---|---|---|
| Procedure | Other | Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules Receives: Procedure: Low-dose computed tomography of the chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of trained radiologists for lung cancer screening
Sensitivity, specificity, predictive values compared to double reading by experts
Measured: 2 years
Secondary outcomes (10)
Effectiveness of screening
Proportion of participants with a positive screening test and proportion of confirmed diagnosis of cancer
Measured: 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
Measured: 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
Measured: 2 years
Analysis of the concordances of the different readings
Kappa concordance coefficient between the different readings
Measured: 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
Measured: 2 years
Analysis of the impact of screening on smoking cessation
Smoking cessation rate at the end of the study
Measured: 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
Measured: 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)
Measured: 2 years
Evaluation of costs induced by screening
Cost measures: total cost of screening, average cost per woman, average cost per woman screened
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start8 Apr 2022
- Primary completion8 Oct 2027 (estimated)
- Study completion8 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,635 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministère de la Santé et des Solidarités, National Cancer Institute, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre REVEL, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisMarie WISLEZ, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195385
- Sponsor's protocol ID
- APHP210362
- Other IDs
- 2021-A02265-36
- Acronym
- CASCADE
- Status last verified
- Mar 2026
- First submitted
- 4 Jan 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36600392
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
- ClinicalTrials.gov ID
- NCT05195385
- Acronym / sponsor ID
- CASCADE / APHP210362
- Conditions
- Lung Cancer Screening
- Keywords
- lung neoplasms, multidetector computed tomography, early detection of cancer, artificial intelligence, lung cancer screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,635 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministère de la Santé et des Solidarités, National Cancer Institute, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 8 Oct 2027 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure | Other | Procedure: Low-dose computed tomography of the chestBaseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose computed tomography of the chestBaseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules | Procedure or surgery | Procedure |
Primary outcome
Performance of trained radiologists for lung cancer screening
Time frame: 2 years
Sensitivity, specificity, predictive values compared to double reading by experts
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 36600392Revel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Pierre REVEL, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Marie WISLEZ, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose computed tomography of the chest in people with Lung Cancer Screening, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Pierre REVEL, PhD (+33 1 42 34 79 10, marie-pierre.revel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of trained radiologists for lung cancer screening (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.