Lung Cancer Registry

NCT04654364 | Recruiting DMC

• 1 other identifier: AGMT_LungCA-Reg
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer; NSCLC Stage IV; NSCLC, Stage III; SCLC, Extensive Stage; SCLC, Limited Stage

Outcome Measures

Primary Outcomes (10)

• General characteristics

  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)

  10 years

• Molecular testing

  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

  10 years

• Characterize subgroups

  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

  10 years

• Treatment duration

  To describe duration of treatment

  10 years

• Treatment frequency

  To describe frequency of treatment

  10 years

• Degree of treatment response

  To describe degree of treatment response in %

  10 years

• Treatment sequence

  To describe sequence of use of various treatments

  10 years

• Outcome OS

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

  10 years

• Outcome PFS

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

  10 years

• Toxicity of treatment

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

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (3)

Universitätsklinik für Innere Medizin III, PMU Salzburg

Salzburg, Salzburg, 5020, Austria

RECRUITING

Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologie

Linz, Upper Austria, 4021, Austria

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Richard Greil, MD

  AGMT gemeinnützige GmbH

  STUDY CHAIR

Central Study Contacts

Daniela Wolkersdorfer

CONTACT

+436626404412; office@agmt.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 4, 2020
• Study Start: August 18, 2020
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)