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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
screening based on clinical presentation	Number and percentage of patients with modalities of diagnosis and screening at the yearly data cut-off based on clinical presentation	5 years
Incidental diagnosis	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)	5 years
TNM staging	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	5 years
Histological type	Number and percentage of patients presenting with lung cancer diagnosis. Histological type	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age categories	Relationship between the diagnosis at early stage and following characteristics - Age categories	5 years
smoking categories.	Relationship between the diagnosis at early stage with smoking categories	5 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lung cancer; Non small cell lung cancer; Early stage; Locally advanced; Aggregate data; data extraction; Late stage
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D133HR00049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 shared.
• IPD Sharing 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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing 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.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No