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NCT Number: NCT06842056

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Early stage (stage I and II with [N0])

    Time frame: 5 years

    Number and percentage of patients diagnosed with Early stage (stage I and II with [N0]) from baseline year until EOS

  2. Locally advanced (stage II and III [N+])

    Time frame: 5 years

    Number and percentage of patients diagnosed with Locally advanced (stage II and III [N+]) from baseline year until EOS

  3. Late stage (stage IV [M1])

    Time frame: 5 years

    Number and percentage of patients diagnosed with Late stage (stage IV [M1]) from baseline year until EOS

Secondary outcomes

  1. screening based on clinical presentation

    Time frame: 5 years

    Number and percentage of patients with modalities of diagnosis and screening at the yearly data cut-off based on clinical presentation

  2. Incidental diagnosis

    Time frame: 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)

  3. TNM staging

    Time frame: 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

  4. Histological type

    Time frame: 5 years

    Number and percentage of patients presenting with lung cancer diagnosis. Histological type

Other outcomes

  1. Age categories

    Time frame: 5 years

    Relationship between the diagnosis at early stage and following characteristics - Age categories

  2. smoking categories.

    Time frame: 5 years

    Relationship between the diagnosis at early stage with smoking categories

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: DIASTAG

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Feb 24, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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