NCT06842056

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Apr 2027

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
2.1 years until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

February 7, 2025

Last Update Submit

May 29, 2026

Conditions

Lung Cancer

Keywords

Lung cancerAggregate dataNon small cell lung cancerdata extractionEarly stageLocally advancedLate stage

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • screening based on clinical presentation

    5 years

  • Incidental diagnosis

    5 years

  • TNM staging

    5 years

  • Histological type

    5 years

Other Outcomes (2)

  • Age categories

    5 years

  • smoking categories.

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 24, 2025

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

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.
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.
More information