Lung CancerANASTASIANCT07617636

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

An observational study of Lung Cancer, run by AstraZeneca at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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… Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Lung Cancer
How many people: 1,500 participants
Where: 1 siteBrazil
Study dates: 30 Dec 2026to 31 Aug 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study 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.

Who may be able to join

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.

Who cannot join

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;

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Individuals undergoing cancer evaluation or treatment;
Individuals exhibiting signs of respiratory distress (nasal flaring, suprasternal retraction, use of accessory muscles, cyanosis);
Pregnancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Brazil1 site

Research Site
São Paulo

Other trials in Brazil

About this study

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

Read the 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.

Conditions: Lung Cancer
Keywords: Lung, Tumor, Artificial Intelligence
Medical subject headings: Lung Neoplasms, Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Lung cancer risk stratification
Measured by the agreement between the results of the Sybil AI model and the LungRADS classifications assigned by the radiologist
Measured: through study completion, an average of 1 year

Secondary outcomes (2)

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.
- 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
Measured: through study completion, an average of 1 year
Histological diagnosis of lung cancer
Confirmed by means of biopsy or surgical specimen with pathological subtyping.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 202631 Aug 2027

First posted1 Jun 2026
Study start30 Dec 2026 (estimated)
Primary completion31 Aug 2027 (estimated)
Study completion31 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 1,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07617636
Sponsor's protocol ID: D133FR00226
Acronym: ANASTASIA
Status last verified: Oct 2026
First submitted: 25 May 2026
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.