The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)

March 23, 2026 updated by: Paolo Milani, Fondazione IRCCS Policlinico San Matteo di Pavia

The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Ancona, Italy
        • Not yet recruiting
        • AOU Ospedali Riuniti
        • Contact:
          • Fabio Vagnarelli, MD
      • Bari, Italy
        • Not yet recruiting
        • Policlinico di Bari
        • Contact:
          • Rita Rizzi, MD
      • Bergamo, Italy
        • Not yet recruiting
        • Asst Papa Giovanni Xxiii
        • Contact:
          • Emilia D'Elia, MD
      • Brescia, Italy
        • Not yet recruiting
        • ASST Spedali Civili di Brescia
        • Contact:
          • Daniela Tomasoni, MD
      • Cagliari, Italy
        • Not yet recruiting
        • Ospedale Oncologico "Armando Businco"
        • Contact:
          • Daniele Derudas, MD
      • Cosenza, Italy
        • Not yet recruiting
        • Azienda Ospedaliera di Cosenza
        • Contact:
          • Enrica Martino, MD
      • Ivrea, Italy
        • Not yet recruiting
        • Presidio ospedaliero di Ivrea
        • Contact:
          • Walter Grosso Marra, MD
      • Milan, Italy
        • Not yet recruiting
        • Asst Santi Paolo E Carlo
        • Contact:
          • Vittorio Montefusco, MD
      • Milan, Italy
        • Not yet recruiting
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
        • Contact:
          • Gloria Santangelo, MD
      • Milan, Italy
        • Not yet recruiting
        • Istituto Auxologico Italiano
        • Contact:
          • Francesco Perelli, MD
      • Milan, Italy
        • Not yet recruiting
        • IRCCS Istituto Clinico Humanitas
        • Contact:
          • Giuseppe Pinto, MD
      • Milan, Italy
        • Not yet recruiting
        • Istituto Monzino
        • Contact:
          • Mauro Contini, MD
      • Monza, Italy
        • Not yet recruiting
        • IRCCS San Gerardo Monza
        • Contact:
          • Daniela Pini, MD
      • Padua, Italy
        • Not yet recruiting
        • 'Azienda Ospedale. Università di Padova
        • Contact:
          • Alberto Cipriani, MD
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
      • Perugia, Italy
        • Not yet recruiting
        • Azienda Ospedaliera di Perugia
        • Contact:
          • Cinzia Zuchi, MD
      • Pescara, Italy
        • Not yet recruiting
        • Ospedale Civile ASL Pescara
        • Contact:
          • Roberta Magnano, MD
      • Roma, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Sant'Andrea
        • Contact:
          • Beatrice Musumeci, MD
      • Roma, Italy
        • Not yet recruiting
        • Ematologia ASL Roma 1
        • Contact:
          • Tommaso Caravita, MD
      • Roma, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli CARDIOLOGIA
        • Contact:
          • Francesca Graziani, MD
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Universitario Agostino Gemelli NEUROLOGIA
        • Contact:
          • Marco Luigetti, MD
      • Salerno, Italy
        • Not yet recruiting
        • Plesso Ospedaliero "Andrea Tortora" di Pagani
        • Contact:
          • Catello Califano, MD
      • Sassari, Italy
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria di Sassari
        • Contact:
          • Giuseppe Damiano Sanna, MD
      • Siena, Italy
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Senese
        • Contact:
          • Elisa Giacomin, MD
      • Torino, Italy
        • Not yet recruiting
        • Ospedale San Giovanni Bosco
        • Contact:
          • Piera Costanzo, MD
      • Treviglio, Italy
        • Not yet recruiting
        • l'Ospedale di Treviglio-Caravaggio
        • Contact:
          • Giovanna Faggiano, MD
      • Vercelli, Italy
        • Not yet recruiting
        • Osp. Sant'Andrea
        • Contact:
          • Lorenzo De Paoli, MD
      • Vicenza, Italy
        • Not yet recruiting
        • Azienda ULSS 8 Berica
        • Contact:
          • Edoardo Scomazzon, MD
    • MI
      • Legnano, MI, Italy
        • Not yet recruiting
        • Asst Ovest Milanese - Ospedale Di Legnano
        • Contact:
          • Corinna Antonia Inserra, MD
    • TO
      • Orbassano, TO, Italy
        • Not yet recruiting
        • AOU San Luigi Gonzaga
        • Contact:
          • Carloalberto Biolè, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

  1. Suspected diagnosis of systemic and localized amyloidosis;
  2. age .18 years;
  3. 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);
  4. planned (or ongoing) follow-up at participating center.

Exclusion Criteria:

1. Diagnosis of light chain (AL) amyloidosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Establishing an online tool for data-sharing, available for health care providers
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-019-IT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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