Nice University Hospital Center
Lung cancer (LC) screening using low-dose chest CT (LDCT) has already proven its efficacy. The mortality reduction associated with LC screening is around 20%, much higher than the reduction in mortality associated with screening for breast, colon or prostate cancers. Implementing lung cancer screening on a large scale faces two main obstacles: The lack of thoracic radiologists and LDCT necessary for the eligible population (between 1.6 and 2.2 million people in France); The high frequency of false positive screenings: in the NLST trial, more than 20% of the subjects screened were found to have at least one nodule of an indeterminate lung nodule (ILN) whereas less than 3% of ILNs are actually LC. The gold standard for determining on the benign or malignant nature of a nodule is definitive histology. Otherwise, the evolution of the nodule on serial thoracic imaging is a good alternative. The period of indeterminacy of a nodule can be as long as 24 months in many cases, which can be a source of prolonged and sometimes unjustified anxiety for screening candidates. The purpose of this randomized controlled study that focuses on LC screening in patients aged 50 to 80 years, who smoked more than 20 packs/ year or stopped smoking less than 15 years ago. Its objective is to determine whether assisting multidisciplinary team (MDT) meetings with an AI-based analysis of screening LDCT accelerates the definitive classification of nodules into malignant or benign.
Lung Cancer
IA
Not IA
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 2722 participants |
Masking : | None (Open Label) |
Primary Purpose : | Diagnostic |
Official Title : | A Randomized Controlled Study of Including a Deep Learning-based Analysis of Chest Computed Tomography as an Aid to Decision Making of Multidisciplinary Team Meetings for Lung Cancer Screening in Eligible Patients |
Actual Study Start Date : | April 8, 2024 |
Estimated Primary Completion Date : | March 1, 2029 |
Estimated Study Completion Date : | October 1, 2030 |
Arm | Intervention/treatment |
---|---|
Experimental: IA Group Patients with at least one nodule (> 6mm) for whom the multidisciplinary team meeting discussion is informed of the AI-based analysis of their chest computed tomography |
Other: IA |
Other: Group not IA analysis Patients with at least one nodule (> 6mm) for whom the multidisciplinary team meeting discussion is not informed of the AI-based analysis of their chest computed tomography |
Other: Not IA |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Nice University Hospital - Pasteur Hospital
Nice, Alpes-maritimes, France, 06001