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

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: Recruiting
• Conditions: ATTR Amyloidosis

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Paolo Milani, MD, PhD; Phone Number: +390382502994; Email: p.milani@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Paolo Milani, MD; Phone Number: +390382502994; Email: p.milani@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: amyloidosis; systemic amyloidosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID 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