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.
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
- Are there results?
- Not yet: the study is under way
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
About this study
Official title: Artificial Intelligence for the Analysis of STAS and Lung Cancer Risk Stratification
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.
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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Sales dos Santos, Doctor, Principal investigator, Fundação Bahiana de Cardiologia - FBC
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for the Analysis of STAS and Lung Cancer Risk Stratification
- ClinicalTrials.gov ID
- NCT07617636
- Acronym / sponsor ID
- ANASTASIA / D133FR00226
- Conditions
- Lung Cancer
- Keywords
- Lung, Tumor, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Individuals of both sexes, smokers or former smokers for a maximum of 15 years;
Key exclusion criteria (9 listed)
- Individuals who are unable to undergo a CT scan;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Ricardo Sales dos Santos, Doctor principal investigator
Fundação Bahiana de Cardiologia - FBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer risk stratification (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.