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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; NSCLC Stage IV; NSCLC, Stage III; SCLC, Extensive Stage; SCLC, Limited Stage

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Daniela Wolkersdorfer; Phone Number: +436626404412; Email: office@agmt.at

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitätsklinik für Innere Medizin III, PMU Salzburg
    • Contact: Florian Huemer, MD
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4021
      • Recruiting
      • Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologie
      • Contact: Bernd Lamprecht, MD
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
      • Contact: Dominik Wolf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 testingPD-L1 % range per disease stagePD-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

Collaborators and Investigators

• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Investigators: Study Chair: Richard Greil, MD, AGMT gemeinnützige GmbH

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: AGMT_LungCA-Reg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No