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)
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).
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)