跳至主要内容
临床试验/NCT06205953
NCT06205953招募中不适用

Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)

Fondazione IRCCS Policlinico San Matteo di Pavia6 个研究点 分布在 6 个国家目标入组 400 人开始时间: 2024年1月1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
400
试验地点
6
主要终点
Mortality at 24 months by stage

研究概览

简要总结

A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.

详细描述

In the frame of the EUREKA Consortium, a patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers across Europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. A dedicated site will support the Consortium with big data analysis and artificial intelligence applied to health. The aims are: 1) Defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of AL patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, MRD).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of systemic AL amyloidosis;
  • treatment-naïve;
  • age ≥18 years;
  • ability to understand and willingness to sign an informed consent;
  • planned follow-up at participating center.

排除标准

  • non-AL amyloidosis;
  • previous treatment for AL amyloidosis.

结局指标

主要结局

Mortality at 24 months by stage

时间窗: 24 months from diagnosis

Mortality at 24 months by stage will be evaluated

次要结局

  • Rate of hematologic relapse in Complete Response patients at 2 years by MRD status(2 years from diagnosis)

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

Giovanni Palladini

MD, PhD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (6)

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