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AzTrials

AmyloidosisNCT07172243

BE.Amycon Biobank & Data Registry UZ Leuven

An observational study of Amyloidosis and AL Amyloidosis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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". Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyloidosis, AL Amyloidosis, Amyloidosis Cardiac
How many people
505 participants
Where
2 sitesBelgium
Study dates
24 Sep 2025to Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients diagnosed with amyloidosis

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michel Delforge contact

+32 16 346880

michel.delforge@uzleuven.be

Belgium2 sites, 2 recruiting

  • UZ Leuven Gasthuisberg - hematology

    Leuven, 3000

    Michel Delforge, Prof.

    Recruiting

  • UZ Leuven Gasthuisberg - cardiology

    Leuven

    Lucas Van Aelst, Prof., +32 16344263

    Recruiting

Other trials in Belgium

About this study

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

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".

Read the detailed description

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.

Medical subject headings
Amyloidosis, Immunoglobulin Light-chain Amyloidosis, Amyloid Neuropathies, Familial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establishment of a data registry: participant baseline demographics

    Demographic characteristics of amyloidosis participants will be assessed at baseline.

    Measured: Baseline

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

    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.

    Measured: Baseline

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

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

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

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

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

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

Secondary outcomes (5)

  1. Best Response

    Documentation of response rates per line of treatment

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

  2. Duration of response

    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.

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

  3. Time to Next Treatment (TTNT)

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

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

  4. Overall Survival (OS)

    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).

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

  5. Progression-free survival (PFS)

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start24 Sep 2025
  3. Primary completionSep 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
505 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172243
Sponsor's protocol ID
BE.AMYCON_UZL_WP2_02
Status last verified
Sep 2026
First submitted
20 Aug 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available upon signed MTA and DTA and approval by steering committee meeting and ethics committee.

Questions about this trial

What is this clinical trial studying?

An observational study of Amyloidosis and AL Amyloidosis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michel Delforge (+32 16 346880, michel.delforge@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establishment of a data registry: participant baseline demographics (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07172243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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