Clinical trial · Observational
Observational Study That Will Analyse the Spread and Stratification of Lung Cancer Risk Using Artificial Intelligence
Artificial Intelligence for the Analysis of STAS and Lung Cancer Risk Stratification
NCT07617636CI-TRIAL-00125944ANASTASIAnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Lung cancer risk stratification
- timeFrame
- through study completion, an average of 1 year
- description
- Measured by the agreement between the results of the Sybil AI model and the LungRADS classifications assigned by the radiologist
Secondary outcomes (2)
- measure
- Presence of STAs
- timeFrame
- through study completion, an average of 1 year
- description
- 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
- measure
- Histological diagnosis of lung cancer
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.