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NCT05704920
Integrating Artificial Intelligence Into Lung Cancer Screening.
Conditions: Lung Cancer
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 2722
Sponsor: Centre Hospitalier Universitaire de Nice
Location: France
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age between 50 and 80 years oldactive smoker or ex-smoker who quit smoking less than 15 years agosmoking history of at least 20 pack-yearssignature of the informed consentaffiliation to French social securityExclusion Criteria:clinical signs suggestive of cancerrecent chest scan (<1 year) for another causeradiological abnormality requiring follow-up or additional investigationshealth problem significantly limiting life expectancy from the clinician's point of viewhealth problem limiting ability or willingness to undergo lung surgeryPatients with active neoplasia, except basal cell carcinoma of the skin.vulnerable people: adults under guardianship, adults under curatorship medical and/or psychiatric problems of sufficient severity to limit full adherence to the study or expose patients to excessive risk
Source: ClinicalTrials.gov (NCT05704920). StuddyBuddy aggregates publicly available trial information.