About this trial
Observational cohort study involving individuals of both sexes with a history of smoking, residing in municipalities in the state of Bahia and attended by the mobile unit, with the aim of evaluating the integration of artificial intelligence (AI) in the detection of pulmonary nodules and the prediction of ASCT in high-risk individuals undergoing CT screening.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals of both sexes, smokers or former smokers for a maximum of 15 years;
Smoking history of 20 pack-years or more;
Between 50 and 80 years old;
Provision of Free and Informed Consent in writing, signed and dated.
Disqualifiers
Individuals who are unable to undergo a CT scan;
Individuals who cannot tolerate lying on their back for more than 10 minutes continuously;
Individuals who present with symptoms highly suggestive of lung cancer (hemoptysis, chest pain, altered cough pattern, unintentional weight loss greater than 10 kg);
Diagnosis of severe heart disease while using multiple medications;
Trial population
The study population includes individuals at high risk for lung cancer enrolled in the ProPulmão screening program. A convenience sample of 1,500 high-risk individuals will be included.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Lung cancer risk stratification
Measured by the agreement between the results of the Sybil AI model and the LungRADS classifications assigned by the radiologist
Secondary outcomes
Presence of STAs
Conceptual definition: STAS is a histopathological finding in lung adenocarcinoma, in which tumor cells are observed disseminated in the alveolar spaces beyond the main tumor margin. o Operational definition: Presence of STAS confirmed by centralized histopathological review of lung tissue samples (biopsy or resection). The review is performed by pathologists who are unfamiliar with IA/radiological assessments
Histological diagnosis of lung cancer
Confirmed by means of biopsy or surgical specimen with pathological subtyping.
Sponsors and contacts
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