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临床试验/NCT07519356
NCT07519356招募中不适用

A Comprehensive Register Of Lymphoproliferative Disorders (ReLy)

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2022年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
9,000
试验地点
1
主要终点
To evaluate 10 year overall survival (OS) of each lymphoproliferative disorder.

研究概览

简要总结

The primary objective of this study is to assess the 10-year overall survival (OS) of patients with different lymphoproliferative disorders. Secondary objectives include evaluating the comorbidities and fitness of patients and their impact on treatment choices and outcomes. Additionally, the study will examine the effectiveness of various therapeutic regimens, with a particular focus on new treatments, such as chemo-free protocols, targeted drugs, and cell therapies, in order to determine the best treatment sequence for refractory and relapsed cases.

The research will also investigate how clinical and biological factors influence disease progression or relapse. Another aim is to explore potential correlations between genotype, clinical phenotype, and outcomes, both at diagnosis and during various disease stages. The study will also assess the incidence of tumor lysis syndrome and other adverse events during treatment, considering how these factors might affect treatment discontinuations or dose reductions.

Another objective is to evaluate the outcomes of patients who are managed with a "watch and wait" approach. Long-term toxicities and the occurrence of secondary malignancies will also be studied, alongside the analysis of healthcare costs and the resources used in patient management.

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

入选标准

  • Patients ≥ 18 years diagnosed with and/or treated for lymphoproliferative disorders.
  • Prospective patients (or their or legal guardians) who have the ability to understand and be willing to sign a written informed consent document
  • Retrospective patients who have signed the institutional document allowing the use of their data for research on their disease

排除标准

  • Patients who are unable to understand informed consent document

研究组 & 干预措施

LNH B

malignant tumor of the lymphatic system originating from the uncontrolled proliferation of B lymphocytes,

LNH T/NK

A heterogeneous and rare group of blood cancers (hematological malignancies) that originate from the malignant transformation of mature T lymphocytes or natural killer (NK) cells.

Hodgkin

It is a tumor of the lymphatic system, characterized by the presence of Reed-Sternberg cells, which usually originates in the lymph nodes.

Immunodeficiency-associated

conditions characterized by abnormal lymphoid tissue growth, ranging from benign to malignant lymphomas, resulting from immune dysregulation

Hystiocitic and dendritic cell neoplasms

a rare, heterogeneous group of hematologic malignancies originating from the mononuclear phagocyte system (monocytes, macrophages, and dendritic cells)

结局指标

主要结局

To evaluate 10 year overall survival (OS) of each lymphoproliferative disorder.

时间窗: from 2002 to 2030

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Arcaini

MD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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