JOURNAL ONKOLOGIE – STUDIE

Lung Cancer Registry

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04654364

Studienbeginn:
August 2020

Letztes Update:
29.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborator:
-

Studienleiter

Richard Greil, MD
Principal Investigator
Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg, Austria

Kontakt

Daniela Wolkersdorfer
Kontakt:
Phone: +436626404412
E-Mail: office@agmt.at» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologie
4021 Linz
AustriaRekrutierend» Google-Maps

Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
6020 Innsbruck
AustriaRekrutierend» Google-Maps

Universitätsklinik für Innere Medizin III, PMU Salzburg
5020 Salzburg
AustriaRekrutierend» Google-Maps

Studien-Informationen

Detailed Description:

This registry is designed as multicenter observational cohort of patients with lung cancer.

Patient medical, testing and treatment information will be obtained through extraction of

data from existing patient medical charts. Longitudinal follow-up data, including survival

and tumor progression, will also be extracted from patient medical charts. This patient

follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required

than those already necessary in general. Participation in the registry must not interfere

with treatment routines. Only routine data, which has already been recorded in the patient's

medical chart, is transferred to the electronic Case Report Forms. To maintain patient

confidentiality, each patient will be assigned a unique patient identifying number upon

enrollment; this number will accompany the patient's medical and other registry information

throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is

required from deceased patients.

Data will be collected from all sites willing to participate.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- stage III A-C and IV A-B NSCLC

- limited disease (LD) and extensive disease (ED) SCLC)

- patients ≥ 18 years

Exclusion Criteria:

- Due to the non-interventional design of the registry there are no specific exclusion

criteria.

Studien-Rationale

Primary outcome:

1. General characteristics (Time Frame - 10 years):
To describe the general characteristics of advanced or metastatic stage patients in Austria (Stage III A-C and IV A-B NSCLC, limited disease (LD) and extensive disease (ED) SCLC)

2. Molecular testing (Time Frame - 10 years):
To describe molecular testing in patients with advanced or metastatic lung cancer number of patients with molecular testing methods for molecular testing number of patients with PD-L1 testing PD-L1 % range per disease stage PD-L1 test antibody used number of genes tested number of patients with at least one mutation identified number of patients with at least one druggable target identified

3. Characterize subgroups (Time Frame - 10 years):
To describe and characterize subgroups Number of patients with NSCLC Number of patients that receive immune-checkpoint inhibitors Number of patients with targetable/druggable mutations

4. Treatment duration (Time Frame - 10 years):
To describe duration of treatment

5. Treatment frequency (Time Frame - 10 years):
To describe frequency of treatment

6. Degree of treatment response (Time Frame - 10 years):
To describe degree of treatment response in %

7. Treatment sequence (Time Frame - 10 years):
To describe sequence of use of various treatments

8. Outcome OS (Time Frame - 10 years):
To describe patient outcome by means of overall survival (OS) in %

9. Outcome PFS (Time Frame - 10 years):
To describe patient outcome by means of progression free survival (PFS) in %

10. Toxicity of treatment (Time Frame - 10 years):
To describe number of patients with toxicity of treatment with a focus on immune related adverse events

Quelle: ClinicalTrials.gov

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