The Italian Transthyretin Amyloidosis Web-Network

ATTR Amyloidosis Clinical Trial

— ITA-WebNet  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444920
• Other study ID #: AC-019-IT
• Status: Recruiting
• Start date: July 13, 2022
• Est. completion date: November 1, 2027

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Matteo
• Contact: Paolo Milani, MD, PhD
• Phone: +390382502994
• Email: p.milani[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• ATTR Amyloidosis

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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