Clinical trial NCT04654364: Lung Cancer Registry
Official title: Lung Cancer Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
NSCLC Stage IV
NSCLC, Stage III
SCLC, Extensive Stage
SCLC, Limited Stage
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The registry will be made available for all disciplines and physicians caring for cancer patients with locally advanced or metastatic lung cancer in Austria. In a first step patients with diagnosis after 01.01.2019 will be included. In a second step the registry will be expanded to include patients with diagnosis before 01.01.2019.

Brief summary: 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.

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.

Primary outcomes:
measure: General characteristics
timeFrame: 10 years
measure: Molecular testing
timeFrame: 10 years
measure: Characterize subgroups
timeFrame: 10 years
measure: Treatment duration
timeFrame: 10 years
measure: Treatment frequency
timeFrame: 10 years
measure: Degree of treatment response
timeFrame: 10 years
measure: Treatment sequence
timeFrame: 10 years
measure: Outcome OS
timeFrame: 10 years
measure: Outcome PFS
timeFrame: 10 years
measure: Toxicity of treatment
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologie
state: Oberösterreich
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
state: Tirol
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III, PMU Salzburg
Study officials:
affiliation: AGMT gemeinnützige GmbH
name: Richard Greil, MD
role: STUDY_CHAIR
References: