IRB Study Number 25-199
Status Recruiting
Location Cleveland Clinic Weston Hospital
Institute Taussig Cancer Institute
Description
Primary Objective
To screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm.
Aim 1: Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study.
Aim 2: Validating an NGS assay that identifies IGVL genes in clonal plasma cells.
Inclusion Criteria
Patients 40 years of age and older diagnosed with SMM with dFLC greater than 23 mg/L and abnormal κ::λ FLC ratio. If the patient has an eGFR less than 50 mL/min/1.73m2, the κ::λ FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criteria in this case.
Exclusion Criteria
Patients with a previous finding of amyloid in other biopsies will not be included.
Patients younger than 40 years of age are not eligible.
Adults unable to consent are not eligible, including the cognitively impaired.
Pregnant women, pregnant minors, minors (i.e., individuals who are not yet adults), wards of the state, non-viable neonates, neonates of uncertain viability, and prisoners are not eligible.
