Clinical trial NCT06842056: Multinational Observational Study to Describe Diagnostic Stage Shift in Patients With Lung Cancer Using Medical Records
Official title: Multicentric Multinational Observational Study to Describe the Shift in Stage at Diagnosis of Lung Cancer. No Direct Recruitment of Patients or Administration of Study Medication.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: Lung cancer
Aggregate data
Non small cell lung cancer
data extraction
Early stage
Locally advanced
Late stage
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study does not involve direct recruitment of the patients. Aggregated data from the databases for each consecutive year starting from the baseline year until End of study. Patients with lung cancer meeting the following criteria will be included in the study.

Brief summary: Multinational observational study to describe diagnostic stage shift in patients with lung cancer using medical records. Increased lung cancer screening programs and increased utilization of other screening modalities such as large increase in community chest radiography referral rates in response to public awareness campaigns, as well as unintentional detections through cardiac CT(computed tomography) angiograms, or screening for coronary disease may help in detecting the disease at earlier curable stages. Availability and increased access to novel therapies increase the likelihood of an early-stage diagnosis aiming for improved survival.

Detailed description: This is a multicentric, multinational, observational study to describe the shift in stage at diagnosis of lung cancer over the time- period from baseline year to EOS (end of study). The study will be implemented in the AstraZeneca International Region (ie, non-US, non-European countries). The participating countries and sites will be selected based on the availability and accessibility of secondary data sources such as lung cancer databases or EMR (electronic medical records) in the target countries. Once countries and databases are selected, the protocol will be adapted for the specific country including details about the patient databases. The study will be conducted in compliance with the local legal, ethical, and regulatory requirements of the selected countries. The study-specific data will be extracted from the databases and recorded using eCRF (electronic case report form). This study does not involve direct recruitment of the patients. Aggregated data from the databases for each consecutive year starting from the baseline year until EOS, of patients with lung cancer meeting the inclusion criteria will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Adult female and male patients ≥18 years old.
* Confirmed diagnosis of lung cancer (either cytologically or histologically)

Exclusion Criteria:

* Patients presenting with recurrent or relapsed lung cancer.
* Patients with a concomitant cancer at the time of diagnosis of lung cancer, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms: a cancer will be considered concomitant if it occurs within 5 years of lung cancer diagnosis.

Primary outcomes:
measure: Early stage (stage I and II with [N0])
timeFrame: 5 years
measure: Locally advanced (stage II and III [N+])
timeFrame: 5 years
measure: Late stage (stage IV [M1])
timeFrame: 5 years
Secondary outcomes:
measure: screening based on clinical presentation
timeFrame: 5 years
measure: Incidental diagnosis
timeFrame: 5 years
measure: TNM staging
timeFrame: 5 years
measure: Histological type
timeFrame: 5 years
Other outcomes:
measure: Age categories
timeFrame: 5 years
measure: smoking categories.
timeFrame: 5 years
Locations:
Study officials:
References: