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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00669-38 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose computed tomography of the chest | Procedure | Baseline low dose Ct acquisition, then at 1 year to depict suspicious lung nodules |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of completion of screening scan | Rate of completion of screening scan, one year after initial scan. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of tobacco consumption | Comparison of tobacco consumption at 1 year versus consumption at baseline | 12 months |
| 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. |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Céline BUFFEL du VAURE, PhD | Contact | 06 61 90 03 71 | +33 | celine.buffel-du-vaure@u-paris.fr |
| Alice CAMARA, MSc | Contact | 01 58 41 12 11 | +33 | alice.camara@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Céline BUFFEL du VAURE, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Marie-Pierre REVEL, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36061495 | Background | 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. | |
| 21714641 | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 12 months |
| Chronic obstructive pulmonary disease (COPD) | Number of participants with initially unrecognized COPD confirmed by lung function tests. | Up to 12 months |
| Statin/aspirin prevention | Number of participants for whom statin/aspirin prevention is initiated following initial scan. | Up to 12 months. |
| Osteoporosis | Number of participants with osteoporosis not known at inclusion confirmed by bone densitometry. | Up to 12 months. |
| Other pathologies | Number of other pathologies confirmed by their reference examination. | Up to 18 months |
| Cancer screened | Rate of stage I cancers among screened cancers. | Up to 18 months |
| Characteristics of eligible population refusing screening : age | Age of eligible people refusing screening | Day 0 |
| Characteristics of eligible population refusing screening : sex | Sex of eligible people refusing screening | Day 0 |
| Characteristics of eligible population refusing screening : smoking status | Smoking status of eligible people refusing screening | Day 0 |
| Characteristics of eligible population refusing screening : level of education | Level of education of eligible people refusing screening | Day 0 |
| Characteristics of eligible population refusing screening : reason for refusal | Reason for refusal of eligible people refusing screening | Day 0 |
| Christian GHASAROSSIAN, MD, PhD |
| Assistance Publique - Hôpitaux de Paris |
| Study Director |
| 30937431 | 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. |
| 31995683 | 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. |
| 8717600 | 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. |
| 29773566 | 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. |
| 34764039 | 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. |
| 25851842 | 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. |
| 30661748 | 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. |
| 23448956 | 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. |
| 20829542 | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |