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

AL Amyloidosis Clinical Trial

— EUREKA  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205953
• Other study ID #: AC-021-EU
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: IRCCS Policlinico S. Matteo
• Contact: Giovanni Palladini
• Phone: +390382502994
• Email: segreteria.amiloidosi[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis

Locations

Country	Name	City	State
Germany	Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672	Heidelberg
Italy	Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100	Pavia
Netherlands	UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan	Utrecht
Spain	Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra	Pamplona
Switzerland	University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics	Muttenz

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 24 months by stage	Mortality at 24 months by stage will be evaluated	24 months from diagnosis
Secondary	Rate of hematologic relapse in Complete Response patients at 2 years by MRD status	Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated	2 years from diagnosis