AGMT Austrian Lymphoma Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Proportion of lymphoma patients in Austria that require treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The registry will include patients ≥ 18 years with lymphoma.
排除标准
- •There are no specific exclusion criteria.
结局指标
主要结局
Proportion of lymphoma patients in Austria that require treatment
时间窗: 10 years
To describe the proportion of lymphoma patients in Austria that require treatment
Proportion of lymphoma patients in Austria under active surveillance
时间窗: 10 years
To describe the proportion of lymphoma patients in Austria under active surveillance
Number of patients with concomitant diseases
时间窗: 10 years
To describe concomitant diseases at diagnosis of lymphoma
General Characteristics
时间窗: 10 years
To describe general characteristics of lymphoma patients
Patient Outcome
时间窗: 10 years
To describe patient's outcome
Genetic Profiling
时间窗: 10 years
To describe genetic risk profiles
Toxicities
时间窗: 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.)
Number of treatment and outcome of treatment
时间窗: 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
次要结局
未报告次要终点