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Recruiting NCT04733430

LALUCA Research Platform A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice

Observational Lung Cancer

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. Basic parameters: 18 years — 125 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 →
Official title

Landsteiner Lung Cancer Research Platform (LALUCA) A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice

Overview

This is a prospective analysis of the diagnosis and treatment of lung cancer in a real-world setting. The aim of the project is to establish a clinical platform to collect representative data on molecular testing, sequence of systemic tumor therapy and other therapies, and disease progression of patients with lung cancer. A special focus will be on molecular biomarker testing and reflex NGS testing. Another aim of the registry is the collection of quality indicators in lung cancer care. The results of the register will be used to describe the current state of care and to develop it further for the future.

Detailed description

The identification of driver-mutations, whose gene product can be specifically inhibited by targeted therapies, has markedly changed the diagnostic and therapeutic landscape for this tumor entity, leading to improved outcomes for patients with metastatic NSCLC.

The use of next generation sequencing (NGS) allows for detection of a multitude of different druggable mutations. In absence of a curative treatment approach and a druggable mutation the prognosis of lung cancer remains poor.

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-Iife practice, is crucial to evaluate and improve the quality of care for patients with lung cancer.

The purpose of this project is to set up a clinical platform to document representative data on molecular testing, sequence of systemic treatment and other treatment modalities, and course of disease in patients with lung cancer. A particular focus is on molecular biomarker testing and NGS of patients before the start of first-line treatment. The data shall be used to assess the current state of care and to develop recommendations concerning topics that can be improved.

Primary outcome measures

  • NGS Testing [Time frame: through study completion, an average of 5 years]

Eligibility criteria

Inclusion criteria

  • Informed consent
  • Histologically confirmed lung cancer
  • Age ≥ 18 years
  • Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments

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
Ecologic or community

Study locations

Austria · 1 center
  • Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie — Vienna

Identifiers

NCT: NCT04733430 · LALUCA Project Plan Version 5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗