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A Registry of AL Amyloidosis (ReAL) (ReAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839003
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
GIOVANNI PALLADINI, IRCCS Policlinico S. Matteo

Study Description
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Brief Summary:
The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Condition or disease
AL Amyloidosis

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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 : February 27, 2020
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Creation of a registry of patients with AL amyloidosis [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
It will be generated a biobank of body fluids (serum, plasma, urine) and relevant cellular (bone marrow and peripheral blood mononuclear cells) and tissue samples (bone marrow, periumbilical fat, possibly other biopsied organs) from patients with AL amyloidosis. We will obtain research samples from diagnostic leftovers of consenting patients at diagnosis and at each subsequent visit.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839003


Locations
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Italy
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Giovanni Palladini, MD    +390382502994    giovanni.palladini@unipv.it   
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
More Information
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Responsible Party: GIOVANNI PALLADINI, Principal Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT04839003    
Other Study ID Numbers: AC-018-IT
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GIOVANNI PALLADINI, IRCCS Policlinico S. Matteo:
amyloidosis
prognosis
registry
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paraproteinemias