JOURNAL ONKOLOGIE – STUDIE

AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT06250465

Studienbeginn:
März 2022

Letztes Update:
14.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell

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, Austria

Kontakt

Daniela Wolkersdorfer
Kontakt:
Phone: +43 662 640 44 12
E-Mail: office@agmt.at» Kontaktdaten anzeigen

Studienlocations
(3 von 9)

Landeskrankenhaus Feldkirch, Innere Med. II, Interne E
6807 Feldkirch
AustriaRekrutierend» Google-Maps

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

A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
6330 Kufstein
AustriaRekrutierend» Google-Maps

KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie
4020 Linz
AustriaRekrutierend» Google-Maps

Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
4020 Linz
AustriaRekrutierend» Google-Maps

Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
4020 Linz
AustriaRekrutierend» Google-Maps

UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
5020 Salzburg
AustriaRekrutierend» Google-Maps

Univ.-Klinikum St. Pölten, Innere Medizin 1
3100 St.Pölten
AustriaRekrutierend» Google-Maps

Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
4600 Wels
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Sonja Heibl, MD» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

Detailed Description:

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

Ein-/Ausschlusskriterien

Inclusion Criteria:

- The registry will include patients ≥ 18 years with CLL.

Exclusion Criteria:

- There are no specific exclusion criteria.

Studien-Rationale

Primary outcome:

1. General Characteristics (Time Frame - 7 years):
To describe general characteristics of CLL patients

2. Genetic Profiling (Time Frame - 7 years):
To describe genetic risk profiles

3. Proportion of CLL patients in Austria that require treatment (Time Frame - 7 years):
To describe the proportion of CLL patients in Austria that require treatment

4. Number of patients with concomitant diseases (Time Frame - 7 years):
To describe concomitant diseases at diagnosis of CLL

5. Number and type of treatment (Time Frame - 7 years):
To describe type and duration of treatment of CLL. Number of patients per treatment, number of treatments per patient.

6. Patient Outcome (Time Frame - 7 years):
To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.

7. Toxicities (Time Frame - 7 years):
To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.

Quelle: ClinicalTrials.gov

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