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

NCT ID: NCT04733430

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2030-04-30

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 125 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karl Landsteiner Institute for Lung Research and Pneumological Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georg-Christian Funk, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Medical Department with Pneumology

Locations

Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Georg-Christian Funk, MD

Role: CONTACT

georg-christian.funk@gesundheitsverbund.at

+43 1 4000-2203

Agnes Attoh, BSc

Role: CONTACT

agnes.attoh@extern.gesundheitsverbund.at

+43 1 4000-72203

Facility Contacts

Georg-Christian Funk, MD

Role: primary

georg-christian.funk@gesundheitsverbund.at

+4314000-2203

Agnes Attoh

Role: backup

agnes.attoh@extern.gesundheitsverbund.at

+4314000-72203

Other Identifiers

LALUCA Project Plan Version 5

Identifier Type: -

Identifier Source: org_study_id