Clinical trial NCT04733430: LALUCA Research Platform A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice
Official title: Landsteiner Lung Cancer Research Platform (LALUCA) A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: NGS Testing
Lead sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All unselected patients diagnosed with lung cancer at the research sites. The study is intended to commence at two sites in Vienna, with subsequent invitation of participation of other sites.

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.

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:

-

Primary outcomes:
measure: NGS Testing
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie
Study officials:
affiliation: 2nd Medical Department with Pneumology
name: Georg-Christian Funk, MD
role: PRINCIPAL_INVESTIGATOR
References: