Involvement of General Practitioners in Lung Cancer Screening

NCT06956040 | Recruiting

• 2 other identifiers: APHP2308112024-A00669-38
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Screening; Lung cancer; General practitioners; CT Scan

Outcome Measures

Primary Outcomes (1)

• Rate of completion of screening scan

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

  12 months

Secondary Outcomes (12)

• Evolution of tobacco consumption

  12 months

• Evolution of anxiety

  12 months

• Chronic obstructive pulmonary disease (COPD)

  Up to 12 months

• Statin/aspirin prevention

  Up to 12 months.

• Osteoporosis

  Up to 12 months.

Interventions

Low-dose computed tomography of the chest PROCEDURE

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

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of lung cancer
• Thoracic CT scan performed within the previous year
• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

RECRUITING

Related Publications (11)

• 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.

  PMID: 36061495 BACKGROUND

• 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.

  PMID: 21714641 BACKGROUND

• 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.

  PMID: 30937431 BACKGROUND

• 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.

  PMID: 31995683 BACKGROUND

• 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.

  PMID: 8717600 BACKGROUND

• 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.

  PMID: 29773566 BACKGROUND

• 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.

  PMID: 34764039 BACKGROUND

• 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.

  PMID: 25851842 BACKGROUND

• 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.

  PMID: 30661748 BACKGROUND

• 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.

  PMID: 23448956 BACKGROUND

• 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.

  PMID: 20829542 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Céline BUFFEL du VAURE, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Marie-Pierre REVEL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Christian GHASAROSSIAN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Céline BUFFEL du VAURE, PhD

CONTACT

06 61 90 03 71; celine.buffel-du-vaure@u-paris.fr

Alice CAMARA, MSc

CONTACT

01 58 41 12 11; alice.camara@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)