ClinicalTrials.gov record NCT07172243
BE.Amycon Biobank & Data Registry UZ Leuven
BE.Amycon Biobank & Data Registry UZ Leuven: Human Body Material (HBM) Collection and Data Collection of Patients With Amyloidosis
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 observational study sets up a GDPR-compliant biobank and a data registry for people with suspected or confirmed amyloidosis. It collects biological samples (blood, urine, tissue) and clinical information about disease presentation, treatments, responses, and outcomes. Samples may be collected for up to 2 years and clinical follow-up recorded for up to 10 years.
What it is studying. To create a human body material biobank and a clinical data registry to support future research into how amyloidosis presents, progresses, is treated, and how patients respond and survive.
What the researchers hope to learn. Establish a GDPR-compliant biobank and a data registry for all amyloidosis subtypes; collect and store blood, urine, and tissue samples; record baseline disease characteristics, treatments, response rates, duration of response, time to next treatment, progression-free survival, and overall survival to enable future scientific research.
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.
After giving informed consent, participants allow collection and storage of biological samples (blood, urine, and tissue when available) for the BE.Amycon biobank and permit entry of their clinical and personal health data into the BE.Amycon data registry. The registry will record diagnosis details, organ involvement, treatments, responses and outcomes as part of routine clinical care; clinical follow-up data may be collected for up to 10 years and biological samples may be collected/stored for up to 2 years. Participation mainly involves providing samples and allowing access to medical records and routine follow-up information.
How the study is structured. A prospective observational cohort. Participants give consent for collection and storage of biological samples and for their clinical data to be entered into a registry. Sample collection is planned up to 2 years; clinical data and follow-up may be recorded up to 10 years.
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 wild-type ATTR amyloidosis
This trial is also listed on this site under AL amyloidosis and ATTRv amyloidosis.
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.
- Michel Delforge 📞 +32 16 346880 ✉ michel.delforge@uzleuven.be
Participating sites (2)
- UZ Leuven Gasthuisberg - hematologyRecruiting
Leuven, 3000 · Belgium
- Michel Delforge, Prof.
- UZ Leuven Gasthuisberg - cardiologyRecruiting
Leuven · Belgium
- Lucas Van Aelst, Prof. · +32 16344263
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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