An observational study in Lung Cancer and Thoracic Tumors, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by AstraZeneca · Observational
A prospective, multicenter, national, observational study involving primary data collection to evaluate the lung cancer detection rate in high-risk never-smokers undergoing LDCT screening, with an exploratory evaluation of an artificial intelligence tool applied to imaging and blood collection for future ctDNA analysis
7,343 studies on the registry are indexed under Lung Neoplasms; 1,562 are open to participants now.
This study's planned enrollment of 200 is close to the median of 190 across 1,554 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of never-smokers who have at least one prespecified high-risk factor for lung cancer, recruited from approximately 10 Brazilian centers.
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Exclusion Criteria:
Never-smoking men aged 50 to 74 and never-smoking women aged 40 to 74 who have at least one pre-specified high-risk factor.
Detection rate of confirmed lung cancer among screened participants
The primary objective is to determine the detection rate of lung cancer, with an emphasis on early-stage disease, in high-risk never-smokers undergoing LDCT screening. The analysis will estimate the rate as the number of participants with a confirmed diagnosis divided by the number of enrolled participants who underwent baseline LDCT.
Time frame: From baseline assessment through the 24-month follow-up period.
Recruitment rate
To estimate the recruitment rate per center and per month.
Time frame: Throughout the enrollment period, ending September 2027.
Retention rate
To estimate the retention rate between the baseline round and the 24-month follow-up assessment.
Time frame: From baseline to 24 months.
Prevalence of lung cancer detected at baseline
To describe the prevalence of lung cancer detected at the baseline visit.
Time frame: At baseline visit.
Incidence of lung cancer over follow-up
To describe the incidence of lung cancer over the follow-up period.
Time frame: Over the 24-month follow-up period.
Diagnostic accuracy of LDCT
To evaluate the diagnostic accuracy of LDCT in detecting lung cancer, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Time frame: Through study completion, approximately at 24 months.
Distribution of radiological findings
To describe the distribution of radiological findings, Lung-RADS v1.0 categories, additional procedures, referrals, and the false-positive rate.
Time frame: Through study completion, approximately at 24 months.
Characterization of diagnosed tumors
Characterize the diagnosed tumors according to clinical stage, histology, diagnostic method, and time to diagnostic confirmation.
Time frame: At time of diagnosis.
No study locations are listed for this record.
Plan to share: 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.
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2030, 47 months later.
Of 107 industry-sponsored observational studies under Lung Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 59. This study's planned 47 months is close to that.
Counting every sponsor, half of 692 studies reached it within 56 months; a quarter within 28 and three quarters within 130.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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