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

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06205953

Acronym

EUREKA

Enrollment

400

Registered

2024-01-16

Start date

2024-01-01

Completion date

2026-06-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AL Amyloidosis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Mortality at 24 months by stage	24 months from diagnosis	Mortality at 24 months by stage will be evaluated

Secondary

Measure	Time frame	Description
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

Countries

Germany, Italy, Netherlands, Spain, Switzerland, Uruguay

Contacts

CONTACTGiovanni Palladini

segreteria.amiloidosi@smatteo.pv.it+390382502994

Outcome results