Observational Study That Will Analyse the Spread and Stratification of Lung Cancer Risk Using Artificial Intelligence

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorAstraZeneca

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Lung cancer risk stratification

Measured by the agreement between the results of the Sybil AI model and the LungRADS classifications assigned by the radiologist

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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

Time frame
through study completion, an average of 1 year
2

Histological diagnosis of lung cancer

Confirmed by means of biopsy or surgical specimen with pathological subtyping.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: