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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2024年1月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
AL Amyloidosis
发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
入组人数
400
试验地点
6
主要终点
Mortality at 24 months by stage
状态
招募中
最后更新
16天前

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).

注册库
clinicaltrials.gov
开始日期
2024年1月1日
结束日期
2026年6月1日
最后更新
16天前
研究类型
Observational
性别
All

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
责任方
Principal Investigator
主要研究者

Giovanni Palladini

MD, PhD

Fondazione IRCCS Policlinico San Matteo di Pavia

入排标准

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)

研究点 (6)

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