BE.Amycon Registry UZ Leuven

NCT06998355 | Suspended

• 1 other identifier: BE.AMYCON_UZL_WP2_01
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (3)

• Participant baseline demographics

  Demographic characteristics of amyloidosis participants will be assessed at baseline.

  Baseline

• Participant amyloidosis diagnosis information

  Disease characteristics will be collected at moment of diagnosis.

  Baseline

• Sequence of treatments in participants with amyloidosis

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

  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

  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

  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)

  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)

  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)

  From enrollment of the patient until death, until loss to follow-up or withdrawal of informed consent, whichever comes first, up to 10 years

Interventions

Registry OTHER

observational data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Vlaams Instituut voor Biotechnologie: collaborator

Study Sites (1)

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

Registries

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

BE (1)