Actively Recruiting
Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2026-03-04
100
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the role of a specific molecular change called N-glycosylation in light chains of immunoglobulins in patients with AL amyloidosis and related monoclonal gammopathies. AL amyloidosis is caused by a small clone of plasma cells in the bone marrow that produces toxic light chains prone to forming harmful deposits. The study aims to understand how N-glycosylation affects the disease process, risk assessment, and how the plasma cell clone behaves and responds to treatments. This observational study involves patients diagnosed with monoclonal gammopathies such as AL amyloidosis, MGUS, or multiple myeloma who are planned for peripheral blood sampling, with or without bone marrow aspiration. Participants consent to allowing their clinical data and leftover diagnostic samples to be used for research. The study will collect detailed sequences of light chains and analyze their molecular and clinical characteristics over a two-year period. Participants will provide biological samples and clinical information that researchers will use to create a dataset of full-length light chain sequences and correlate these with clinical features and drug sensitivity. The study will refine methods to predict light chain amyloidogenicity and explore biological and pharmacological impacts of N-glycosylation. Safety monitoring and follow-up details are not specified, and participation duration aligns with the two-year outcome measurement period.
CONDITIONS
Brief Title
Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of monoclonal gammopathy (e.g. AL amyloidosis, MGUS, multiple myeloma, others)
- Planned peripheral blood sampling with or without bone marrow aspiration
- Age 18 years or older
- Willingness to allow use of clinical data and leftover diagnostic specimens for research by signing informed consent
You will not qualify if you...
- Lack of monoclonal gammopathy
- Complete hematologic response after anti-clonal therapy
- Age younger than 18 years
- Unwillingness to allow use of clinical data and leftover diagnostic specimens for research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants provide peripheral blood samples and may also have bone marrow aspiration as part of the observational study.
Visits occur as needed for sample collection over the study period
Duration - Up to 2 years
Participants are observed for clinical and biologic correlates related to N-glycosylation in AL amyloidosis.
Periodic visits as determined by clinical care
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, PV, Italy, 27100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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