Lung Cancer Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer, NSCLC Stage IV, NSCLC, Stage III, SCLC, Extensive Stage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- General characteristics [Time frame: 10 years]
- Molecular testing [Time frame: 10 years]
- Characterize subgroups [Time frame: 10 years]
- Treatment duration [Time frame: 10 years]
- Treatment frequency [Time frame: 10 years]
- Degree of treatment response [Time frame: 10 years]
- Treatment sequence [Time frame: 10 years]
- Outcome OS [Time frame: 10 years]
- Outcome PFS [Time frame: 10 years]
- Toxicity of treatment [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- stage III A-C and IV A-B NSCLC
- limited disease (LD) and extensive disease (ED) SCLC)
- patients ≥ 18 years
Exclusion criteria
\- Due to the non-interventional design of the registry there are no specific exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Austria · 3 centers
- 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
Identifiers
NCT: NCT04654364 · AGMT_LungCA-Reg