A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)

Recruiting

• Conditions: AL Amyloidosis

• Registration Number: NCT06205953
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at 24 months by stage	24 months from diagnosis	Mortality at 24 months by stage will be evaluated

Secondary Outcome Measures

Name	Time	Method
Rate of hematologic relapse in Complete Response patients at 2 years by MRD status	2 years from diagnosis	Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated

Trial Locations

Locations (6)

Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela"; 🇺🇾 Montevideo, Uruguay

Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672; 🇩🇪 Heidelberg, Germany

Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100; 🇮🇹 Pavia, Italy

UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan; 🇳🇱 Utrecht, Netherlands

Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra; 🇪🇸 Pamplona, Spain

University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics; 🇨🇭 Muttenz, Switzerland