Observational Study That Will Analyse the Spread and Stratification of Lung Cancer Risk Using Artificial Intelligence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artificial Intelligence for the Analysis of STAS and Lung Cancer Risk Stratification
Overview
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.
Detailed description
The main objective of the study is compare the performance of a Sybil AI tool with the LungRADS classifications assigned by radiologists for the risk stratification of pulmonary nodules. Furthermore, it aims to assess the correlation between the AI-predicted STAS and histopathological confirmation, alongside imaging and AI results. The hypothesis is that the Sybil AI model will demonstrate comparable predictive accuracy and that the features predicted by the AI will correlate with the presence of STAS.
Primary outcome measures
- Lung cancer risk stratification [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- Presence of STAs [Time frame: through study completion, an average of 1 year]
- Histological diagnosis of lung cancer [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Diagnosis of severe lung disease, using multiple medications and/or requiring home oxygen therapy;
- History of radiation therapy to the chest area;
- Individuals undergoing cancer evaluation or treatment;
- Individuals exhibiting signs of respiratory distress (nasal flaring, suprasternal retraction, use of accessory muscles, cyanosis);
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Research Site — São Paulo
Identifiers
NCT: NCT07617636 · D133FR00226