Hôpital Cochin
Paris, 75014, France
Location status: Recruiting
Location contact
Céline BUFFET du VAURE, PhD
CONTACT
Marie-Pierre REVEL, PhD
CONTACT
NCT Number: NCT06956040
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.
Interested in participating?
Request Info50 year–74 year
All sexes
Interventional
Not applicable
Paris, 75014, France
Location status: Recruiting
Céline BUFFET du VAURE, PhD
CONTACT
Marie-Pierre REVEL, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Baseline low dose Ct acquisition, then at 1 year to depict suspicious lung nodules
Time frame: 12 months
Rate of completion of screening scan, one year after initial scan.
Time frame: 12 months
Comparison of tobacco consumption at 1 year versus consumption at baseline
Time frame: 12 months
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.
Time frame: Up to 12 months
Number of participants with initially unrecognized COPD confirmed by lung function tests.
Time frame: Up to 12 months.
Number of participants for whom statin/aspirin prevention is initiated following initial scan.
Time frame: Up to 12 months.
Number of participants with osteoporosis not known at inclusion confirmed by bone densitometry.
Time frame: Up to 18 months
Number of other pathologies confirmed by their reference examination.
Time frame: Up to 18 months
Rate of stage I cancers among screened cancers.
Time frame: Day 0
Age of eligible people refusing screening
Time frame: Day 0
Sex of eligible people refusing screening
Time frame: Day 0
Smoking status of eligible people refusing screening
Time frame: Day 0
Level of education of eligible people refusing screening
Time frame: Day 0
Reason for refusal of eligible people refusing screening
Contact information is provided by the study sponsor or research team.
Alice CAMARA, MSc
CONTACT
01 58 41 12 11 ext. +33
Céline BUFFEL du VAURE, PhD
CONTACT
06 61 90 03 71 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Acronym: GEDEPIST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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