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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Georg-Christian Funk, MD; Phone Number: +43 1 4000-2203; Email: georg-christian.funk@gesundheitsverbund.at
• Study Contact Backup: Name: Agnes Attoh, BSc; Phone Number: +43 1 4000-72203; Email: agnes.attoh@extern.gesundheitsverbund.at

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Recruiting
    • Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie
    • Contact: Georg-Christian Funk, MD; Phone Number: +4314000-2203; Email: georg-christian.funk@gesundheitsverbund.at
    • Contact: Agnes Attoh; Phone Number: +4314000-72203; Email: agnes.attoh@extern.gesundheitsverbund.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 125 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
• Investigators: Principal Investigator: Georg-Christian Funk, MD, 2nd Medical Department with Pneumology

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: NGS Testing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LALUCA Project Plan Version 5

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