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.
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
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.
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven Gasthuisberg - hematology
Leuven, 3000
Michel Delforge, Prof.
- Recruiting
UZ Leuven Gasthuisberg - cardiology
Leuven
Lucas Van Aelst, Prof., +32 16344263
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.
- Conditions
- Amyloidosis, AL Amyloidosis, Amyloidosis Cardiac
- 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.
Establishment of a data registry: participant baseline demographics
Demographic characteristics of amyloidosis participants will be assessed at baseline.
Measured: Baseline
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
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
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)
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
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.
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.
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
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.
- First posted15 Sep 2025
- Study start24 Sep 2025
- Primary completionSep 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Responsible party
- Sponsor
- Investigators
- Michel Delforge, Principal investigator, UZ Leuven GasthuisbergJoost Schymkowitz, Prof., Principal investigator, VIB - Switch LabFrederic Rousseau, Prof., Principal investigator, VIB - Switch Lab
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.