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NCT Number: NCT06205953

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality at 24 months by stage

    Time frame: 24 months from diagnosis

    Mortality at 24 months by stage will be evaluated

Secondary outcomes

  1. Rate of hematologic relapse in Complete Response patients at 2 years by MRD status

    Time frame: 2 years from diagnosis

    Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Palladini

CONTACT

[email protected]

+390382502994

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study 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)

Acronym: EUREKA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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