Multinational Observational Study to Describe Diagnostic Stage Shift in Patients With Lung Cancer Using Medical Records

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06842056
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Study Start: 2025-03-15
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early stage (stage I and II with [N0])	5 years	Number and percentage of patients diagnosed with Early stage (stage I and II with \[N0\]) from baseline year until EOS
Locally advanced (stage II and III [N+])	5 years	Number and percentage of patients diagnosed with Locally advanced (stage II and III \[N+\]) from baseline year until EOS
Late stage (stage IV [M1])	5 years	Number and percentage of patients diagnosed with Late stage (stage IV \[M1\]) from baseline year until EOS

Secondary Outcome Measures

Name	Time	Method
screening based on clinical presentation	5 years	Number and percentage of patients with modalities of diagnosis and screening at the yearly data cut-off based on clinical presentation
Incidental diagnosis	5 years	Number and percentage of patients with Incidental diagnosis o Through screening program (Yes/No) If yes, screening modality (LDCT/ sputum microscopy/ chest X-ray/ any other)
TNM staging	5 years	Number and percentage of patients presenting with TNM staging according to AJCC 8th edition (Aberle, 2011;Kutob, 2019) or staging by alternative lung cancer staging system
Histological type	5 years	Number and percentage of patients presenting with lung cancer diagnosis. Histological type