NCT07617636

Brief 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 high-risk individuals undergoing CT screening.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Aug 2027

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

May 25, 2026

Last Update Submit

June 26, 2026

Conditions

Lung Cancer

Keywords

LungTumorArtificial Intelligence

Outcome Measures

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

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Presence of STAs

    through study completion, an average of 1 year

  • Histological diagnosis of lung cancer

    through study completion, an average of 1 year

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

São Paulo, Brazil

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ricardo Sales dos Santos, Doctor

    Fundação Bahiana de Cardiologia - FBC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

BR(1)