Lung Cancer Registry

Lung Cancer Clinical Trial

Official title:

Lung Cancer Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654364
• Other study ID #: AGMT_LungCA-Reg
• Status: Recruiting
• Start date: August 18, 2020
• Est. completion date: August 2030

Study information

• Verified date: February 2024
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: Daniela Wolkersdorfer
• Phone: +436626404412
• Email: office[@]agmt.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.

This malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.

Despite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2030
• Est. primary completion date: August 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• NSCLC Stage IV
• NSCLC, Stage III
• SCLC, Extensive Stage
• SCLC, Limited Stage

Locations

Country	Name	City	State
Austria	Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken	Innsbruck	Tirol
Austria	Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologie	Linz	Oberösterreich
Austria	Universitätsklinik für Innere Medizin III, PMU Salzburg	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General characteristics	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)	10 years
Primary	Molecular testing	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	10 years
Primary	Characterize subgroups	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	10 years
Primary	Treatment duration	To describe duration of treatment	10 years
Primary	Treatment frequency	To describe frequency of treatment	10 years
Primary	Degree of treatment response	To describe degree of treatment response in %	10 years
Primary	Treatment sequence	To describe sequence of use of various treatments	10 years
Primary	Outcome OS	To describe patient outcome by means of overall survival (OS) in %	10 years
Primary	Outcome PFS	To describe patient outcome by means of progression free survival (PFS) in %	10 years
Primary	Toxicity of treatment	To describe number of patients with toxicity of treatment with a focus on immune related adverse events	10 years