Clinical trial NCT06998355: BE.Amycon Registry UZ Leuven
Official title: BE.Amycon Amyloidosis Data Registry UZ Leuven
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amyloidosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Vlaams Instituut voor Biotechnologie
First posted: 2025-05-31
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for the study are newly diagnosed amyloidosis patients and amyloidosis patients in follow up at UZ Leuven Gasthuisberg at moment of EC approval.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant baseline demographics
timeFrame: Baseline
measure: Participant amyloidosis diagnosis information
timeFrame: Baseline
measure: Sequence of treatments in participants with amyloidosis
timeFrame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Secondary outcomes:
measure: Best Response
timeFrame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
measure: Duration of response
timeFrame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
measure: Time to Next Treatment (TTNT)
timeFrame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
measure: Overall Survival (OS)
timeFrame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
measure: Progression-free survival (PFS)
timeFrame: From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
Study officials:
References: