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NCT Number: NCT06998355

BE.Amycon Registry UZ Leuven

The goal of this observational study is to establish database with (limited) personal and health data of patients diagnosed with amyloidosis (any subtype) in order to get better insights on the disease presentation, disease evolution pattern, treatment plans and responses and survival.

Why the study stopped: Merged with other trial
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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

About this study

With the support of VIB 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.

In this context, a registry of clinical data is a requirement for both improvement of diagnostics as well as fundamental research purposes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Provide consent and sign informed consent form
  • Confirmed diagnosis of amyloidosis (any subtype), systemic and/or localised
  • Newly diagnosed or in follow-up during the study time-frame (1 JUN 2025 until 31 DEC 2027)

Exclusion criteria

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

Treatment and study plan

Registry

Other

observational data collection

Primary outcomes

  1. Participant baseline demographics

    Time frame: Baseline

    Demographic characteristics of amyloidosis participants will be assessed at baseline.

  2. Participant amyloidosis diagnosis information

    Time frame: Baseline

    Disease characteristics will be collected at moment of diagnosis.

  3. Sequence of treatments 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

    Treatment sequences for participants with amyloidosis within routine clinical care will be assessed.

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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Flemish institute of biotechnology (VIB)

Registry information

Official study title

BE.Amycon Amyloidosis Data Registry UZ Leuven

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 31, 2025
Registry last updated
Sep 25, 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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