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

Sponsor
Karl Landsteiner Institute for Lung Research and Pneumological Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT04733430
Collaborator
(none)
500
Enrollment
1
Location
119.5
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Landsteiner Lung Cancer Research Platform (LALUCA) A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice
    Actual Study Start Date :
    Apr 17, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2030
    Anticipated Study Completion Date :
    Apr 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 125 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie Vienna Austria 1160

    Sponsors and Collaborators

    • Karl Landsteiner Institute for Lung Research and Pneumological Oncology

    Investigators

    • Principal Investigator: Georg-Christian Funk, MD, 2nd Medical Department with Pneumology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karl Landsteiner Institute for Lung Research and Pneumological Oncology
    ClinicalTrials.gov Identifier:
    NCT04733430
    Other Study ID Numbers:
    • LALUCA Project Plan Version 5
    First Posted:
    Feb 2, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karl Landsteiner Institute for Lung Research and Pneumological Oncology
    NGS Testing
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2022