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NCT Number: NCT04654364

Lung Cancer Registry

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC Stage IV NSCLC, Stage III Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms SCLC, Extensive Stage SCLC, Limited Stage Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Innere Medizin III, PMU Salzburg, Salzburg, State of Salzburg, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. General characteristics

    Time frame: 10 years

    To describe the general characteristics of advanced or metastatic stage patients in Austria (Stage III A-C and IV A-B NSCLC, limited disease (LD) and extensive disease (ED) SCLC)

  2. Molecular testing

    Time frame: 10 years

    To describe molecular testing in patients with advanced or metastatic lung cancer

    • number of patients with molecular testing
    • methods for molecular testing
    • number of patients with PD-L1 testing
    • PD-L1 % range per disease stage
    • PD-L1 test antibody used
    • number of genes tested
    • number of patients with at least one mutation identified
    • number of patients with at least one druggable target identified

  3. Characterize subgroups

    Time frame: 10 years

    To describe and characterize subgroups

    • Number of patients with NSCLC
    • Number of patients that receive immune-checkpoint inhibitors
    • Number of patients with targetable/druggable mutations

  4. Treatment duration

    Time frame: 10 years

    To describe duration of treatment

  5. Treatment frequency

    Time frame: 10 years

    To describe frequency of treatment

  6. Degree of treatment response

    Time frame: 10 years

    To describe degree of treatment response in %

  7. Treatment sequence

    Time frame: 10 years

    To describe sequence of use of various treatments

  8. Outcome OS

    Time frame: 10 years

    To describe patient outcome by means of overall survival (OS) in %

  9. Outcome PFS

    Time frame: 10 years

    To describe patient outcome by means of progression free survival (PFS) in %

  10. Toxicity of treatment

    Time frame: 10 years

    To describe number of patients with toxicity of treatment with a focus on immune related adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Wolkersdorfer

CONTACT

[email protected]

+436626404412

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 4, 2020
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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