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Lung CancerGEDEPISTNCT06956040

Involvement of General Practitioners in Lung Cancer Screening

A study testing Low-dose computed tomography of the chest in people with Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective is to evaluate the adherence of smoking patients to lung cancer screening by low-dose CT scan, when proposed by the general practitioner. Read more about this study

Who is it for?
Ages 50 to 74 years
Conditions the study is for
Lung Cancer
What is being tested?
Low-dose computed tomography of the chest
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteFrance
Study dates
2 Jun 2025to Dec 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 50-74
  • Active smoker or weaned smoker for less than 15 years, of at least 20 pack-years
  • Affiliation with a social security scheme or CMU (beneficiary or beneficiary entitled)
  • Written informed consent prior to study participation

Who cannot join

  • History of lung cancer
  • Thoracic CT scan performed within the previous year
  • 1-year follow-up not possible
  • Inability to travel independently to Hôpital Cochin or Hôpital Bichat for scans
  • People with severe co-morbidities contraindicating exploration and/or management of lung cancers
  • People in poor general health (=PS2 and above)
Show all 12Show fewer
  • People with a history of cancer under active surveillance by thoracic computed tomography (CT and PET scans)
  • People with rest dyspnea (=mMRC4)
  • Recent weight loss, altered general condition or hemoptysis, raising suspicion of progressive lung cancer
  • Signs of respiratory infection (fever, productive cough)
  • Patients under guardianship, curatorship or protected adults
  • Inability to give free written informed consent prior to study participation

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
  • Hôpital Cochin

    Paris, 75014

    Céline BUFFET du VAURE, PhD, celine.buffel-du-vaure@u-paris.fr

    Marie-Pierre REVEL, PhD, marie-pierre.revel@aphp.fr

    Recruiting

Other trials in France

About this study

The main objective is to evaluate the adherence of smoking patients to lung cancer screening by low-dose CT scan, when proposed by the general practitioner.

Read the detailed description

Lung cancer is the leading cause of cancer mortality in France and worldwide. The KBP2020 study conducted in general hospitals, including 8999 patients diagnosed with lung cancer in the year 2020, showed that 73% of lung cancer cases were diagnosed at an advanced symptomatic stage, explaining the high rate of metastatic status at diagnosis, reaching 58%. For this category of patients, 3-month mortality remains very high, close to 25%. Several large randomized studies have demonstrated that lung cancer screening with low-dose CT scans enables lung cancer to be diagnosed at an early, asymptomatic stage, when it is mostly accessible to curative surgical treatment. This early detection and subsequent treatment reduced specific mortality by 20% in the NLST study, and by up to 39% at 10 years in the MILD study. Overall mortality was reduced by 6.7% in the NLST study. This scientific evidence has led the French National Authority for Health to encourage the implementation of a pilot program, to be organized by the French National Cancer Institute.

The hypothesis of the study is that the proposal of CT screening for lung cancer will be better adhered to if it is made by the general practitioner of individuals at risk. Adherence is defined by an initial scan, followed by a second scan one year after the first, with participation in screening on an annual basis.

Given the trust that generally characterizes the relationship between patients and their GP, and the fact that intercurrent consultations provide reminders of the need for an annual check-up, the assumption is for an initial participation rate of at least 50%, and a continued participation rate of 70% at 1 year.

Communication of results by the GP will help to limit anxiety, particularly in the event of an undetermined result, which will be assessed by the anxiety section of the Hospital Anxiety and Depression scale questionnaire translated into French.

In addition, the success of smoking cessation will be compared with literature data in the context of screening. The hypothesis is that the cessation rate will be higher due to the possibility of adapting nicotine substitution by the GP and his or her repeated support in the cessation process.

Finally, knowledge of patients' histories will help to limit unnecessary explorations and to better identify for which participants screening reveals COPD (emphysema), osteoporosis or unrecognized coronary artery disease.

Conditions
Lung Cancer
Being tested
Low-dose computed tomography of the chest
Keywords
Screening, Lung cancer, General practitioners, CT Scan
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 to depict suspicious lung nodules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of completion of screening scan

    Rate of completion of screening scan, one year after initial scan.

    Measured: 12 months

Secondary outcomes (12)
  1. Evolution of tobacco consumption

    Comparison of tobacco consumption at 1 year versus consumption at baseline

    Measured: 12 months

  2. Evolution of anxiety

    Hospital Anxiety and Depression Scale score (anxiety section) completed by the participant at the initial scan, at 1 year (and any additional scans), at follow-up consultations with the GP (and any additional scans) and at the end of the study.

    The minimum score is 0 and the maximum is 21. Higher score means worse outcome.

    Measured: 12 months

  3. Chronic obstructive pulmonary disease (COPD)

    Number of participants with initially unrecognized COPD confirmed by lung function tests.

    Measured: Up to 12 months

  4. Statin/aspirin prevention

    Number of participants for whom statin/aspirin prevention is initiated following initial scan.

    Measured: Up to 12 months.

  5. Osteoporosis

    Number of participants with osteoporosis not known at inclusion confirmed by bone densitometry.

    Measured: Up to 12 months.

  6. Other pathologies

    Number of other pathologies confirmed by their reference examination.

    Measured: Up to 18 months

  7. Cancer screened

    Rate of stage I cancers among screened cancers.

    Measured: Up to 18 months

  8. Characteristics of eligible population refusing screening : age

    Age of eligible people refusing screening

    Measured: Day 0

  9. Characteristics of eligible population refusing screening : sex

    Sex of eligible people refusing screening

    Measured: Day 0

  10. Characteristics of eligible population refusing screening : smoking status

    Smoking status of eligible people refusing screening

    Measured: Day 0

  11. Characteristics of eligible population refusing screening : level of education

    Level of education of eligible people refusing screening

    Measured: Day 0

  12. Characteristics of eligible population refusing screening : reason for refusal

    Reason for refusal of eligible people refusing screening

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2025
  2. Study start2 Jun 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956040
Sponsor's protocol ID
APHP230811
Other IDs
2024-A00669-38
Acronym
GEDEPIST
Status last verified
Sep 2025
First submitted
25 Apr 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rosell R, Gonzalez-Cao M. Ablating lung cancer, knowing the tumor better. Lancet Reg Health Eur. 2022 Aug 26;22:100494. doi: 10.1016/j.lanepe.2022.100494. eCollection 2022 Nov. No abstract available.

    PubMed 36061495
  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

    PubMed 21714641
  • Pastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Jul 1;30(7):1162-1169. doi: 10.1093/annonc/mdz117.

    PubMed 30937431
  • de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.

    PubMed 31995683
  • Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.

    PubMed 8717600
  • From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Hussain MS, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2018 Jun;39(6):E61-E76. doi: 10.3174/ajnr.A5638. Epub 2018 May 17. No abstract available.

    PubMed 29773566
  • Leleu O, Basille D, Auquier M, Clarot C, Hoguet E, Baud M, Lenel S, Milleron B, Berna P, Jounieaux V. Results of Second Round Lung Cancer Screening by Low-Dose CT scan - French Cohort Study (DEP-KP80). Clin Lung Cancer. 2022 Jan;23(1):e54-e59. doi: 10.1016/j.cllc.2021.09.009. Epub 2021 Oct 10.

    PubMed 34764039
  • Aubin-Auger I, Laouenan C, Le Bel J, Mercier A, Baruch D, Lebeau JP, Youssefian A, Le Trung T, Peremans L, Van Royen P. Efficacy of communication skills training on colorectal cancer screening by GPs: a cluster randomised controlled trial. Eur J Cancer Care (Engl). 2016 Jan;25(1):18-26. doi: 10.1111/ecc.12310. Epub 2015 Apr 6.

    PubMed 25851842
  • Aim-Eusebi A, Cussac F, Aubin-Auger I. [Cancer prevention and screening: What french GPs could do?]. Bull Cancer. 2019 Jul-Aug;106(7-8):707-713. doi: 10.1016/j.bulcan.2018.11.015. Epub 2019 Jan 17. French.

    PubMed 30661748
  • Custers JA, van den Berg SW, van Laarhoven HW, Bleiker EM, Gielissen MF, Prins JB. The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors. Cancer Nurs. 2014 Jan-Feb;37(1):E44-50. doi: 10.1097/NCC.0b013e3182813a17.

    PubMed 23448956
  • Shemesh J, Henschke CI, Shaham D, Yip R, Farooqi AO, Cham MD, McCauley DI, Chen M, Smith JP, Libby DM, Pasmantier MW, Yankelevitz DF. Ordinal scoring of coronary artery calcifications on low-dose CT scans of the chest is predictive of death from cardiovascular disease. Radiology. 2010 Nov;257(2):541-8. doi: 10.1148/radiol.10100383. Epub 2010 Sep 9.

    PubMed 20829542

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, 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 12 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 20 Nov 2025. 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 Céline BUFFEL du VAURE, PhD (06 61 90 03 71 ext. +33, celine.buffel-du-vaure@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of completion of screening scan (time frame: 12 months). 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 NCT06956040, which also lists 11 linked publications.

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 20 Nov 2025.

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