Clinical trial NCT06294652: AGMT Austrian Lymphoma Registry
Official title: AGMT Austrian Lymphoma Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Keywords: Lymphoma
Diffuse large B-cel lymphoma (DLBCL)
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Interested sites that treat patients in this indication will be invited to participate in this registry.

Brief summary: Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).

There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted.

Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups.

Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities.

Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis.

Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus.

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.

Eligibility criteria: Inclusion Criteria:

* The registry will include patients ≥ 18 years with lymphoma.

Exclusion Criteria:

* There are no specific exclusion criteria.

Primary outcomes:
measure: General Characteristics
timeFrame: 10 years
measure: Genetic Profiling
timeFrame: 10 years
measure: Proportion of lymphoma patients in Austria that require treatment
timeFrame: 10 years
measure: Proportion of lymphoma patients in Austria under active surveillance
timeFrame: 10 years
measure: Number of patients with concomitant diseases
timeFrame: 10 years
measure: Number of treatment and outcome of treatment
timeFrame: 10 years
measure: Patient Outcome
timeFrame: 10 years
measure: Toxicities
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III, PMU Salzburg
Study officials:
affiliation: Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg, Austria
name: Richard Greil, MD
role: PRINCIPAL_INVESTIGATOR
References: