Lung Cancer Registry

Обзор

Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women. This malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported. Despite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.

Подробное описание

This registry is designed as multicenter observational cohort of patients with lung cancer. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Data will be collected from all sites willing to participate.

Первичные конечные точки

• General characteristics [Срок оценки: 10 years]
• Molecular testing [Срок оценки: 10 years]
• Characterize subgroups [Срок оценки: 10 years]
• Treatment duration [Срок оценки: 10 years]
• Treatment frequency [Срок оценки: 10 years]
• Degree of treatment response [Срок оценки: 10 years]
• Treatment sequence [Срок оценки: 10 years]
• Outcome OS [Срок оценки: 10 years]
• Outcome PFS [Срок оценки: 10 years]
• Toxicity of treatment [Срок оценки: 10 years]

Критерии участия

Критерии включения

• stage III A-C and IV A-B NSCLC
• limited disease (LD) and extensive disease (ED) SCLC)
• patients ≥ 18 years

Критерии исключения

\- Due to the non-interventional design of the registry there are no specific exclusion criteria.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Австрия · 3 центра

• Universitätsklinik für Innere Medizin III, PMU Salzburg — Salzburg
• Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätsklini — Innsbruck
• Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologi — Linz

Идентификаторы

NCT: NCT04654364 · AGMT_LungCA-Reg

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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