BE.Amycon Registry UZ Leuven

Suspended

• Conditions: Amyloidosis

• Registration Number: NCT06998355
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-31
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-28
• Study Start: 2025-09-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sequence of treatments in participants with amyloidosis	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.
Participant baseline demographics	Baseline	Demographic characteristics of amyloidosis participants will be assessed at baseline.
Participant amyloidosis diagnosis information	Baseline	Disease characteristics will be collected at moment of diagnosis.

Secondary Outcome Measures

Name	Time	Method
Best Response	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.
Duration of response	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.
Time to Next Treatment (TTNT)	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.
Overall Survival (OS)	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).
Progression-free survival (PFS)	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).

Trial Locations

Locations (1)

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium