NCT04839003

Brief Summary

The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Feb 2020May 2027

Study Start

First participant enrolled

February 27, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

7.2 years

First QC Date

March 22, 2021

Last Update Submit

April 13, 2026

Conditions

AL Amyloidosis

Keywords

amyloidosisprognosisregistry

Outcome Measures

Primary Outcomes (1)

  • Creation of a registry of patients with AL amyloidosis

    5 years

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes.

You may qualify if:

  • diagnosis of systemic AL amyloidosis;
  • treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
  • age ≥18 years;
  • ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
  • planned (or ongoing) follow-up at participating center.

You may not qualify if:

  • non-AL amyloidosis;
  • previous treatment for AL amyloidosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

It will be generated a biobank of body fluids (serum, plasma, urine) and relevant cellular (bone marrow and peripheral blood mononuclear cells) and tissue samples (bone marrow, periumbilical fat, possibly other biopsied organs) from patients with AL amyloidosis. We will obtain research samples from diagnostic leftovers of consenting patients at diagnosis and at each subsequent visit.

MeSH Terms

Conditions

Immunoglobulin Light-chain AmyloidosisAmyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 9, 2021

Study Start

February 27, 2020

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

IT(1)