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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04733430
Other study ID # LALUCA Project Plan Version 5
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 17, 2020
Est. completion date April 2030

Study information

Verified date March 2024
Source Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Contact Georg-Christian Funk, MD
Phone +43 1 4000-2203
Email georg-christian.funk@gesundheitsverbund.at
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 2030
Est. primary completion date April 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 125 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie Vienna

Sponsors (1)

Lead Sponsor Collaborator
Karl Landsteiner Institute for Lung Research and Pneumological Oncology

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary NGS Testing To assess molecular biomarker testing and indicators of the quality of care in patients with lung cancer through study completion, an average of 5 years
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