Clincosm LogoSign in Get a demo

A Registry of AL Amyloidosis (ReAL)

Sponsor
IRCCS Policlinico S. Matteo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04839003
Collaborator
(none)
5,000
Enrollment
1
Location
62.1
Anticipated Duration (Months)
80.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)
    Actual Study Start Date :
    Feb 27, 2020
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    May 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Creation of a registry of patients with AL amyloidosis [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. diagnosis of systemic AL amyloidosis;

    2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part);

    3. age ≥18 years;

    4. 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);

    5. planned (or ongoing) follow-up at participating center.

    Exclusion Criteria:

    1. non-AL amyloidosis;

    2. previous treatment for AL amyloidosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100

    Sponsors and Collaborators

    • IRCCS Policlinico S. Matteo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GIOVANNI PALLADINI, Principal Investigator, IRCCS Policlinico S. Matteo
    ClinicalTrials.gov Identifier:
    NCT04839003
    Other Study ID Numbers:
    • AC-018-IT
    First Posted:
    Apr 9, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by GIOVANNI PALLADINI, Principal Investigator, IRCCS Policlinico S. Matteo
    amyloidosis
    prognosis
    registry
    Additional relevant MeSH terms:
    Immunoglobulin Light-chain Amyloidosis
    Amyloidosis

    Study Results

    No Results Posted as of May 5, 2022