JOURNAL ONKOLOGIE – STUDIE

AGMT Austrian Lymphoma Registry

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT06294652

Studienbeginn:
Februar 2024

Letztes Update:
05.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphoma

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

Studienlocations
(1 von 1)

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

Studien-Informationen

Detailed Description:

This registry is designed as international multicenter observational cohort of patients with

lymphoma. Information on patient´s clinical presentation, tests, diagnosis, and treatment

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 (eCRF). 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 lymphoma.

Exclusion Criteria:

- There are no specific exclusion criteria.

Studien-Rationale

Primary outcome:

1. General Characteristics (Time Frame - 10 years):
To describe general characteristics of lymphoma patients

2. Genetic Profiling (Time Frame - 10 years):
To describe genetic risk profiles

3. Proportion of lymphoma patients in Austria that require treatment (Time Frame - 10 years):
To describe the proportion of lymphoma patients in Austria that require treatment

4. Proportion of lymphoma patients in Austria under active surveillance (Time Frame - 10 years):
To describe the proportion of lymphoma patients in Austria under active surveillance

5. Number of patients with concomitant diseases (Time Frame - 10 years):
To describe concomitant diseases at diagnosis of lymphoma

6. Number of treatment and outcome of treatment (Time Frame - 10 years):
To describe treatment and outcome of treatment, among them historical standard with immunochemotherapy cellular therapies (e.g. Car-T cells) novel immunotherapies such as bispecific antibodies continuous treatment or an induction/maintenance approach sequence of use of various treatments treatment duration treatment adjustments frequency and degree of response

7. Patient Outcome (Time Frame - 10 years):
To describe patient's outcome

8. Toxicities (Time Frame - 10 years):
To describe toxicity with a focus on immunological mediated side effects of treatment (e.g. Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity syndrome (ICAN) etc.)

Quelle: ClinicalTrials.gov

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