Implementing Low-dose ct Lung Cancer Screening in France. (IMPULSION)

The main objective is to estimate the detection rate of lung cancer in the population screened by low-dose chest CT scans.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Low-dose computed tomography of the chest

Detailed Description

Low-dose CT screening (LDCT) allows for the detection of lung cancer at an early stage, enabling curative treatment. Large randomized controlled trials have demonstrated that LDCT reduces mortality in smokers.

The objective of the current research is not to confirm a reduction in mortality, but to show that screening can be safely implemented at a population level. Different modes of recruitment and invitation will be tested to ensure that LDCT can be implemented equitably. The role of artificial intelligence as an alternative to double human reading will also be assessed.

Screening strategy includes baseline, followed by 1-year LDCT, and a third LDCT 2 years later. Current smokers will be offered smoking cessation support.

The management of screen-detected lung nodules will follow the 2025 guidelines from the European Society of Thoracic imaging.

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Pierre REVEL, PhD; Phone Number: +33 01 58 41 24 71; Email: marie-pierre.revel@aphp.fr
• Study Contact Backup: Name: Alice CAMARA, MSc; Phone Number: +33 01 71 76 07 64; Email: alice.camara@aphp.fr

Study Locations

• France
  • France
    • Lyon, France, France, 69495
      • HCL - Hôpital Lyon Sud
      • Contact: Sébastien COURAUD, MD, PHD; Phone Number: +33 04 78 86 44 14; Email: sebastien.couraud@chu-lyon.fr
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Hopital Cochin
      • Contact: Marie-Pierre REVEL, MD, PhD; Phone Number: +33 01 58 41 24 71; Email: marie-pierre.revel@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 50-74 years
• Active or former smoker having quit less than 15 years ago
• Smoking history of at least 20 pack-years, or 15 cigarettes/day for 25 years or 10 cigarettes/day for 30 years
• Affiliation with a social security scheme
• Written informed consent prior to study participation

Temporary exclusion Criteria

• Chest CT scan performed within the previous 12 months
• Signs of respiratory infection (fever, productive cough)

Exclusion Criteria:

• Severe co-morbidities contraindicating exploration and/or management (including stereotactic surgery or radiotherapy) of lung cancers
• Poor general status (PS2 and above)
• Rest dyspnea (mMRC4)
• Cancer under active surveillance by thoracic computed tomography (CT pr PET-CT)
• Personal history of lung cancer
• Symptoms raising suspicion of lung cancer (hemoptysis, unexplained weight loss, recent onset or modification of respiratory symptoms,…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer detection rate in the population screened using low-dose chest CT	Number of individuals with detected cancer divided by the number of individuals included in the study, i.e., an intention-to-screen analysis.	42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of screening performance	True positives: positive screening result and confirmation of malignancy.; True negatives: negative screening result (absence of nodules, or nodules not meeting the criteria for a positive or indeterminate screening, see algorithms), including during retrospective review in cases where cancer is diagnosed within the following year.; False positives: positive screening result but malignancy not confirmed after appropriate investigation(s).; False negatives: CT screening considered negative, but cancer is diagnosed within the coming year and the CT scan is retrospectively interpreted as positive or indeterminate.	42 months
Exploration and comparison of several methods for identifying and inviting the target population	The identification and invitation of participants will be carried out using a multimodal approach: local and national press campaigns, outreach to insured individuals aged 50 to 74 in certain regions, and through an ambassador network (healthcare professionals, institutional representatives, associations, and citizens aware of lung cancer screening). Screening support tools will be deployed, including: A website with a calculator to help determine eligibility;; A telephone call center to assess eligibility. Inclusions : Inclusions will be carried out by the participant's primary care physician if they are an investigator, or by other volunteer general practitioners, in health centers; by secondary care providers; or via outreach programs. The inclusion visits or teleconsultations will allow verifying the eligibility criteria and obtaining electronic consent.	18 months
Measurement of participation rate	The participation rate is defined as the number of individuals having performed at least one CT scan, divided by the number of eligible individuals.	18 months
Measurement of response rates to follow-up invitations	The investigators will measure the participation rate to follow-up invitations following an indeterminate CT scan result	42 months
Measurement of adherence to screening rounds	The investigators will measure the participation rate to screening at 1 year and 3 year	18 months , 30 months & 54 months
Measurement of the complication rate of invasive investigations in positive cases (true positives and false positives)	For participants with a positive screening result, the procedures, results, and complications of diagnostic actions (PET, endoscopy, CT-guided or ultrasound-guided biopsy, surgery) will be collected from the participants' medical records . The rate of early-stage lung cancers among the lung cancers diagnosed following a CT screening will also be measured (Evaluation criterion: number of lung cancers diagnosed at stage I or II divided by the total number of diagnosed lung cancers).	42 months
Measurement of the adherence rate to the offered smoking cessation support	The investigators will record the proportion of active smokers who either decline the systematically offered smoking-cessation assistance or fail to attend the scheduled appointment, as well as the factors underlying this refusal. The investigators will also assess smoking cessation rates during follow-up and identify their predictors.	48 months
Measurement of the adherence rate to smoking cessation support	The investigators will record the proportion of active smokers who declined smoking-cessation support or did not attend the scheduled appointments	48 months
Identification of reasons for refusal of smoking cessation support.	Investigators will collect the reasons selected by participants for refusing smoking cessation support from a pre-established list (e.g., concern about weight gain, fear of failure).	48 months
Measurement of smoking cessation rate	The investigators will assess smoking cessation rates during follow-up and identify their predictors.	48 months
Identification of the predictors of smoking cessation rates.	The investigators will identify the predictor of smoking cessation rates (correlation with age, gender, level of education, occupation, etc…)	48 months
Evaluation of the feasibility and relevance of a double reading of CT scans, and role of artificial intelligence	Agreement in classifying cases as "screen-negative" versus "positive or indeterminate" between a single AI-assisted reading and a double AI-assisted reading (with a third adjudication in case of disagreement, serving as the reference), measured using the kappa coefficient.; Agreement in classifying cases as "screen-negative" versus "positive or indeterminate" between AI alone and the reference, measured using the kappa coefficient.	12 months
Measurement of the detection rate of coronary artery calcifications, pulmonary emphysema, osteoporosis, and incidental findings	For each of these anomalies, the detection rate will be calculated as the number of participants with the anomaly divided by the number of participants who underwent at least one CT scan. The presence and severity of emphysema (Fleischner classification), the Shemesh score, attenuation at the T8 level, and the diameter of the ascending aorta if >4 cm will be systematically recorded in the structured CT screening report. Interstitial lung abnormalities (ILA, including Langerhans cell histiocytosis), osteoporotic compression fractures, and all anomalies requiring clinical care will also be systematically documented.	24 months
Comparison of healthcare pathways	Healthcare utilization will be compared between screening-adherent and non-adherent patients, using two different denominators: the target population and the invited population after linkage with the SNDS (French National Health Data System).	42 months
Creation of a CT scan dataset	As part of the IMPULSION study, an imaging dataset for research and teaching purposes will be created, including all CT scans performed during the study (baseline, follow-up, and subsequent screening rounds), unless the participant explicitly objects.	42 months
Definition of a lung cancer risk score	Using the variables collected in the IMPULSION study, a predictive lung cancer risk score will be developed for the eligible population, specifically tailored to the French population.	42 months
Cost effectiveness analysis	The costs associated with screening (including surgical treatment of early-stage cancers and hospitalization for invasive procedures) will be compared with the costs that would have been incurred if the screen-detected lung cancers had all been diagnosed at an advanced stage.	42 months
Panel characteristics of participants	The objective of this sub-study is to conduct a qualitative analysis of the characteristics of participants in lung cancer screening and the program.	48 months
Panel - participant perceptions	Qualitative assessment of participant perceptions regarding lung cancer screening in a random sample of 2,000 participants enrolled in the main study.	48 months
Ultra low-dose	The objective is to assess whether this dose level, using modern techniques, provides information equivalent to that obtained with the dose used in the main protocol. A second ultra-low-dose acquisition (CTDI 0.15 mGy for weight < 80 kg, CTDI 0.20 mGy for weight ≥ 80 kg) immediatly after the IMPULSION CT scan. The ultra-low-dose CT scan will be read exclusively in a centralized manner by a certified radiologist assisted by AI software, using the same criteria as those applied to the low-dose reference acquisition, and blinded to the low-dose CT data. An assessment of concordance will be performed in 2,500 participants.	1 day (baseline scanner)
Biobank	Collection of a maximum of 28 mL of whole blood (i.e., approximately 7 tubes of 5 mL with 4 mL collected per tube) for storage for research purposes. The collected samples are intended to create a biobank linked to clinical and radiological data. This biobank will make it possible to test various biomarkers for predicting individual cancer risk, the risk that a nodule is cancerous, or the risk of developing a disease evaluated in this cohort (including COPD, cardiovascular disease, osteoporosis, or interstitial lung disease).	Inclusion (day 1)
Spirometry	The purpose of this examination is to assess lung volumes at inclusion visit. In participating an optional, spirometry will be performed at inclusion. The following mesaures will be recorded : FEV1 and FVC. Interpretation will be based on GOLD recommendations and using the GLI system for reference values. The following definitions will be used: Pre-COPD: FEV₁ < 80% and FEV₁/FVC ≥ 0.7; Obstructive ventilatory defect (OVD): FEV₁/FVC < 0.7 on spirometry; GOLD stages 1 to 4 according to the FEV₁ value. Participant questionnaire will also includes questions about chronic COPD symptoms in order to assess the presence of a COPD.	Inclusion (day 1)
Impact of the program on healthcare pathways	The impacts on care pathways can be measured by evaluating the following time intervals, -Time between registration on the platform and completion of the inclusion visit,; Time between inclusion and completion of the initial CT scan,; Time until availability of radiology reports (single and double reading),; Time to first contact with a tobacco cessation specialist AND Using the date of the CT scan as the reference date: Time to presentation of positive cases at the MDTB,; Time to a positive diagnosis (pathological report or MDTB report ); Time to first treatment for positive cases requiring it,; Time to the first thoracic surgery consultation,; Time to surgery; Time to other consultations depending on incidental findings	42 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Marie-Pierre REVEL, PhD, Assistance Publique - Hôpitaux de Paris; Study Chair: Sébastien COURAUD, PhD, Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lung cancer; Screening; Smoking cessation; Computed Tomography; X-Ray
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Behavior; Health Behavior; Lung Neoplasms; Smoking Cessation
• Other Study ID Numbers: APHP250243; ID-RCB Number (Other Identifier: 2025-A00978-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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