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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04733430
• Lead Sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology

Brief Summary

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.

Study Timeline

• Study Start: 2020-04-17
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NGS Testing	through study completion, an average of 5 years	To assess molecular biomarker testing and indicators of the quality of care in patients with lung cancer

Trial Locations

Locations (1)

Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie; 🇦🇹 Vienna, Austria