NCT05444920

Brief Summary

The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

30 active sites

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 Progress72%
Jul 2022Nov 2027

First Submitted

Initial submission to the registry

June 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

June 30, 2022

Last Update Submit

March 23, 2026

Conditions

Keywords

amyloidosissystemic amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Establishing an online tool for data-sharing, available for health care providers

    Different data (types type of organ involvement, biomarkers of organ damage, date of onset of symptoms, date of diagnosis, type of treatment (if any)) will be shared between the health-care professionals and the panel of experts.

    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. Data of deceased patients will be used only if they have expressed their consent to the use of their clinical data

You may qualify if:

  • Suspected diagnosis of systemic and localized amyloidosis;
  • 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:

  • \. Diagnosis of light chain (AL) amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

ASST Ovest Milanese - Ospedale di Legnano

Legnano, MI, Italy

NOT YET RECRUITING

AOU San Luigi Gonzaga

Orbassano, TO, Italy

NOT YET RECRUITING

AOU Ospedali Riuniti

Ancona, Italy

NOT YET RECRUITING

Policlinico di Bari

Bari, Italy

NOT YET RECRUITING

ASST Papa Giovanni XXIII

Bergamo, Italy

NOT YET RECRUITING

ASST Spedali Civili di Brescia

Brescia, Italy

NOT YET RECRUITING

Ospedale Oncologico "Armando Businco"

Cagliari, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Cosenza

Cosenza, Italy

NOT YET RECRUITING

Presidio ospedaliero di Ivrea

Ivrea, Italy

NOT YET RECRUITING

Asst Santi Paolo E Carlo

Milan, Italy

NOT YET RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

IRCCS Istituto Clinico Humanitas

Milan, Italy

NOT YET RECRUITING

Istituto Auxologico Italiano

Milan, Italy

NOT YET RECRUITING

Istituto Monzino

Milan, Italy

NOT YET RECRUITING

IRCCS San Gerardo Monza

Monza, Italy

NOT YET RECRUITING

'Azienda Ospedale. Università di Padova

Padua, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera di Perugia

Perugia, Italy

NOT YET RECRUITING

Ospedale Civile ASL Pescara

Pescara, Italy

NOT YET RECRUITING

Azienda Ospedaliera Sant'Andrea

Roma, Italy

NOT YET RECRUITING

Ematologia ASL Roma 1

Roma, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli CARDIOLOGIA

Roma, Italy

NOT YET RECRUITING

Policlinico Universitario Agostino Gemelli NEUROLOGIA

Roma, Italy

NOT YET RECRUITING

Plesso Ospedaliero "Andrea Tortora" di Pagani

Salerno, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Senese

Siena, Italy

NOT YET RECRUITING

Ospedale San Giovanni Bosco

Torino, Italy

NOT YET RECRUITING

l'Ospedale di Treviglio-Caravaggio

Treviglio, Italy

NOT YET RECRUITING

Osp. Sant'Andrea

Vercelli, Italy

NOT YET RECRUITING

Azienda Ulss 8 Berica

Vicenza, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

AmyloidosisImmunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Central Study Contacts

Paolo Milani, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 6, 2022

Study Start

July 13, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations