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NCT Number: NCT07172243

BE.Amycon Biobank & Data Registry UZ Leuven

The goal of this study is to collect and store human body material (HBM) of patients with amyloidosis in a biobank "BE.Amycon biobank" for future research and to collect clinical data of patients with amyloidosis in a database "BE.Amycon data registry".

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Key information

Conditions

Amyloidosis AL Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Cardiac Amyloidosis, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Metabolism, Inborn Errors Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Paraproteinemias Peripheral Nervous System Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven Gasthuisberg - cardiology, Leuven, Belgium

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About this study

With the support of VIB (Vlaams Instituut voor Biotechnologie) Grand Challenges Program, this project aims to establish the BElgian AMYloidosis CONsortium (BE.AMYCON) by joining forces of VIB researchers, a state-of-the-art diagnostic platform, and clinicians from various disciplines and different institutes. Such a consortium will address patient needs and improve outcomes on many levels.

The aim is is to establish a GDPR (General Data Protection Regulation)-proof HBM biobank in the context of amyloidosis. HBM of patients with suspected or confirmed amyloidosis will be prospectively collected and stored for future scientific research. In addition to the HBM collection, a database with personal and health data of patients diagnosed with amyloidosis (any subtype) will be established in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provide consent and sign informed consent form
  • Age 18 years or older
  • Diagnosis of amyloidosis (suspected or confirmed, any subtypes)
  • For the prospective sample collection only: newly diagnosed (any subtype) or at relapse (AL amyloidosis)

Exclusion criteria

  • Not willing to sign informed consent
  • Not able to sign informed consent

Treatment and study plan

Primary outcomes

  1. Establishment of a data registry: participant baseline demographics

    Time frame: Baseline

    Demographic characteristics of amyloidosis participants will be assessed at baseline.

  2. Establishment of a data registry: description of the disease characteristics of patients with amyloidosis at diagnosis

    Time frame: Baseline

    Disease characteristics of amyloidosis (disease presentation and symptoms, type of organ involvment, results of diagnostic tests (lab values, imaging, biopsy)) will be collected at moment of diagnosis.

  3. Establishment of a data registry: treatment in participants with amyloidosis

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years

    Description of treatment (type of treatment per line of treatment) of participants with amyloidosis within routine clinical care.

  4. Establishment of a biobank with biological samples (blood, urine, tissue) from patients with amyloidosis

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 2 years

    Biological samples (blood, urine, tissue) will be collected from patients with amyloidosis.

Secondary outcomes

  1. Best Response

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years

    Documentation of response rates per line of treatment

  2. Duration of response

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years.

    Duration of response is defined as the time from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.

  3. Time to Next Treatment (TTNT)

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years.

    TTNT is defined as the time from the date of initiation of regimen to the initiation of next regimen for each successive therapy received.

  4. Overall Survival (OS)

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years

    OS is defined as the time from the date of initiation of therapy to the date of death from any cause (or last documented follow-up).

  5. Progression-free survival (PFS)

    Time frame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years

    PFS is defined as the time from the date of initiation of therapy to the date of progression or death of any cause, whichever occurs first (or last documented follow-up).

Study contacts

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

Michel Delforge

CONTACT

[email protected]

+32 16 346880

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Flemish institute of biotechnology (VIB)

Registry information

Official study title

BE.Amycon Biobank & Data Registry UZ Leuven: Human Body Material (HBM) Collection and Data Collection of Patients With Amyloidosis

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 15, 2025
Registry last updated
Feb 27, 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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