AmyloidosisNCT06998355
BE.Amycon Registry UZ Leuven
An observational study of Amyloidosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Registry
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2025to 1 Jun 2028
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Not able to provide informed consent
- Not willing to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BE.Amycon Amyloidosis Data 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.
Read the 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.
- Conditions
- Amyloidosis
- Being tested
- Registry
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
observational data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant baseline demographics
Demographic characteristics of amyloidosis participants will be assessed at baseline.
Measured: Baseline
Participant amyloidosis diagnosis information
Disease characteristics will be collected at moment of diagnosis.
Measured: Baseline
Sequence of treatments in participants with amyloidosis
Treatment sequences for participants with amyloidosis within routine clinical care will be assessed.
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
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 posted31 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: Merged with other trial
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998355
- Sponsor's protocol ID
- BE.AMYCON_UZL_WP2_01
- Status last verified
- Aug 2025
- First submitted
- 12 May 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided