ClinicalTrials.gov record NCT07172243

BE.Amycon Biobank & Data Registry UZ Leuven

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationBelgium
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational registry and biobank collects human body material (blood, urine, tissue) and clinical data from people with suspected or confirmed amyloidosis. The project aims to create a GDPR-compliant biobank (BE.Amycon) and an associated data registry for future scientific research. Clinical data may be followed for up to 10 years and samples stored for up to 2 years according to the registry record.

What it is studying. The study is building a biobank and a linked data registry to enable future research. It aims to collect samples and clinical information to describe how amyloidosis presents, how it evolves over time, what treatments are used, treatment responses, and survival.

What the researchers hope to learn. Establish a GDPR-compliant human body material biobank (BE.Amycon) and a data registry; collect and store biological samples (blood, urine, tissue) from patients with amyloidosis; gather clinical data across amyloidosis subtypes to describe disease presentation, evolution, treatment patterns, treatment responses, and survival; provide a resource for future scientific research by the BE.AMYCON consortium.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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".

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participation involves signing an informed consent form and allowing researchers to collect and record your health and personal data in the BE.AMYCON data registry. Human body material will be collected and stored for the BE.AMYCON biobank; the record specifically lists blood, urine, and tissue samples. The registry will record demographics, disease features at diagnosis, treatments, treatment responses, and survival. Sample collection is planned from enrollment for up to 2 years; clinical data and follow-up are planned from enrollment for up to 10 years or until death, loss to follow-up, or withdrawal of consent.

How the study is structured. This is a prospective observational cohort study (a registry). People who consent give samples (blood, urine, tissue) and have clinical data entered into a database. The study records routine clinical care, treatments, test results, and outcomes over time; it does not assign treatments. The registry plans follow-up of clinical outcomes for up to 10 years and storage of collected samples for up to 2 years as stated in the record.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under AL amyloidosis and wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 24, 2025
Primary completion
September 2029 (estimated)
Study completion
January 2030 (estimated)
Target enrollment
505 participants (estimated)
Last updated on registry
Sep 25, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
  • Flemish institute of biotechnology (VIB)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

  • UZ Leuven Gasthuisberg - hematologyRecruiting

    Leuven, 3000 · Belgium

    • Michel Delforge, Prof.
  • UZ Leuven Gasthuisberg - cardiologyRecruiting

    Leuven · Belgium

Terms used on this page · explanations by MedicalUpdates.ai

biobank
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
relapse
A condition that improved with treatment and has since returned or worsened.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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