How N-glycosylation of light chains affects AL amyloidosis diagnosis and treatment
Official title: Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07448779 · Data updated 2026-11-12
This project will test whether a sugar modification called N-glycosylation on immunoglobulin light chains helps cause disease or changes how AL amyloidosis and related monoclonal gammopathies behave in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, PV) |
| Status | Recruiting |
| Started | November 17, 2025 |
| Main results expected | May 30, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07448779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a diagnosed monoclonal gammopathy such as AL amyloidosis, MGUS, or multiple myeloma who can give informed consent and are scheduled for peripheral blood sampling with or without bone marrow aspiration.
✕Probably not a fit
People without a monoclonal gammopathy, those in complete hematologic response after anti-clonal therapy, children under 18, or anyone unwilling to provide consent or samples are not expected to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project collects peripheral blood and, when planned, bone marrow samples from adults with monoclonal gammopathies and analyzes their immunoglobulin light chains for N-glycosylation and other molecular features. Laboratory methods such as protein sequencing and mass spectrometry will be used to detect glycosylation and structural changes in patient-specific light chains. Clinical data will be correlated with molecular findings to see if N-glycosylation predicts amyloid formation, organ involvement, or different responses to therapy. The goal is to clarify molecular determinants of light chain pathogenicity and identify potential diagnostic markers or stratification features for treatment.
Why it matters
Potential benefit: If successful, this work could lead to better tests to spot harmful light chains and help doctors choose treatments that work best for patients with N-glycosylated light chains.
How similar studies have gone: Anecdotal case reports and small series have linked N-glycosylation to amyloidogenic light chains, but systematic, larger-scale studies testing this mechanism and its clinical impact remain limited, making this approach partly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of monoclonal gammopathy (e.g. AL amyloidosis, MGUS, MM, others) * Planned peripheral blood sampling +/- bone marrow aspiration * Age \> 18 years * Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent. Exclusion Criteria: * Lack of monoclonal gammopathy * Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy * Age \<18 years * Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.
Where it's running
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Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pv, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.