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JOURNAL ONKOLOGIE – STUDIE
Lung Cancer Registry
Rekrutierend
NCT-Nummer:
NCT04654364
Studienbeginn:
August 2020
Letztes Update:
04.12.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Lung Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborator:
-
Studienleiter
Principal Investigator
Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg, Austria
Kontakt
Kontakt:
Phone: +436626404411
E-Mail: office@agmt.at» Kontaktdaten anzeigen
Studienlocations
(3 von 3)
4021 Linz
AustriaRekrutierend» Google-Maps
6020 Innsbruck
AustriaAktiv, nicht rekrutierend» Google-Maps
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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