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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Early stage (stage I and II with [N0]) [Срок оценки: 5 years]
• Locally advanced (stage II and III [N+]) [Срок оценки: 5 years]
• Late stage (stage IV [M1]) [Срок оценки: 5 years]

Вторичные конечные точки (4)

• screening based on clinical presentation [Срок оценки: 5 years]
• Incidental diagnosis [Срок оценки: 5 years]
• TNM staging [Срок оценки: 5 years]
• Histological type [Срок оценки: 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06842056 · D133HR00049

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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