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NCT Number: NCT07617636

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Lung cancer risk stratification

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

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

Secondary outcomes

  1. Presence of STAs

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

    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

  2. Histological diagnosis of lung cancer

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Artificial Intelligence for the Analysis of STAS and Lung Cancer Risk Stratification

Acronym: ANASTASIA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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