IMPLEMENTING LOW-DOSE CT LUNG CANCER SCREENING IN FRANCE
France launches large-scale lung cancer screening trial using low-dose CT scans
Plain English Summary
IMPLEMENTING LOW-DOSE CT LUNG CANCER SCREENING IN FRANCE is a Not Applicable clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Lung Cancer. This trial tests how effective low-dose CT scans are at finding lung cancer in a large group of people. It is for adults aged 50-74 who are current or former smokers with a significant smoking history. Participants will have low-dose CT scans at the start, and at 1 and 3 years, and will need to provide informed consent. Alternatives include symptom-based diagnosis, which may detect cancer at later, less treatable stages. The trial aims to enroll 20000 participants.
Official Summary
The main objective is to estimate the detection rate of lung cancer in the population screened by low-dose chest CT scans.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 74 years old. You must be a current smoker or have quit smoking less than 15 years ago, with a history of smoking at least 20 pack-years. You cannot join if you had a chest CT in the last year, have signs of a respiratory infection, have severe health problems that would prevent cancer treatment, or have a personal history of lung cancer. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to determine how often lung cancer is found in people who are screened with low-dose CT scans over a 42-month period. The specific primary outcome measures are: Lung cancer detection rate in the population screened using low-dose chest CT (42 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to establish a systematic lung cancer screening program in France, addressing the need for early detection in high-risk individuals before symptoms appear. This research targets Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial could pave the way for a national lung cancer screening program, potentially impacting a large market of at-risk individuals and establishing a new standard of care. The large enrollment target of 20000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the criteria and if this screening is right for you. Participation involves undergoing CT scans at specific intervals and providing consent. Day-to-day life should not be significantly impacted, beyond attending scheduled appointments. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 20,000 participants
Interventions
- PROCEDURE: Low-dose computed tomography of the chest — Baseline low-dose CT acquisition, then at 1 year and 3 years to depict suspicious lung nodules
Primary Outcomes
- Lung cancer detection rate in the population screened using low-dose chest CT (42 months)
Secondary Outcomes
- Evaluation of screening performance (42 months)
- Exploration and comparison of several methods for identifying and inviting the target population (18 months)
- Measurement of participation rate (18 months)
- Measurement of response rates to follow-up invitations (42 months)
- Measurement of adherence to screening rounds (18 months , 30 months & 54 months)
Full Eligibility Criteria
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,…)
Trial Locations
- HCL - Hôpital Lyon Sud, Lyon, France, France
- Hôpital Cochin, Paris, Île-de-France Region, France
Frequently Asked Questions
What is clinical trial NCT07513818?
NCT07513818 is a Not Applicable INTERVENTIONAL study titled "IMPLEMENTING LOW-DOSE CT LUNG CANCER SCREENING IN FRANCE." It is currently not yet recruiting and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 20000 participants.
What conditions does NCT07513818 study?
This trial investigates treatments for Lung Cancer. The primary condition under study is Lung Cancer.
What treatments are being tested in NCT07513818?
The interventions being studied include: Low-dose computed tomography of the chest (PROCEDURE). Baseline low-dose CT acquisition, then at 1 year and 3 years to depict suspicious lung nodules
What does Not Applicable mean for NCT07513818?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07513818?
This trial is currently "Not Yet Recruiting." It started on 2026-06. The estimated completion date is 2031-12.
Who is sponsoring NCT07513818?
NCT07513818 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07513818?
The trial aims to enroll 20000 participants. The trial has not yet started recruiting.
How is NCT07513818 designed?
This is a interventional study, uses non_randomized allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07513818?
The primary outcome measures are: Lung cancer detection rate in the population screened using low-dose chest CT (42 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07513818 being conducted?
This trial is being conducted at 2 sites, including Lyon, France; Paris, Île-de-France Region (France).
Where can I find official information about NCT07513818?
The official record for NCT07513818 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07513818. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07513818 testing in simple terms?
This trial tests how effective low-dose CT scans are at finding lung cancer in a large group of people. It is for adults aged 50-74 who are current or former smokers with a significant smoking history.
Why is this trial significant?
This trial aims to establish a systematic lung cancer screening program in France, addressing the need for early detection in high-risk individuals before symptoms appear.
What are the potential risks of participating in NCT07513818?
The main risk is radiation exposure from CT scans, though low-dose scans minimize this. Potential side effects include false positives, leading to anxiety and further unnecessary tests, and false negatives, where cancer is missed. Some participants may experience anxiety or stress related to the screening results. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07513818?
Ask your doctor if you meet the criteria and if this screening is right for you. Participation involves undergoing CT scans at specific intervals and providing consent. Day-to-day life should not be significantly impacted, beyond attending scheduled appointments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07513818 signal from an investment perspective?
This trial could pave the way for a national lung cancer screening program, potentially impacting a large market of at-risk individuals and establishing a new standard of care. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have low-dose CT scans at the start, and at 1 and 3 years, and will need to provide informed consent. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Lung Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.