Primary Objective: To assess the quantity of circulating plasma cells (CPCs) in patients with plasma cell disorders. Primary Endpoint: The quantity of circulating plasma cells (CPCs) in patients with plasma cell disorders and fluctuations in these numbers in patients followed longitudinally through changes in disease burden. Secondary Objective: To assess the qualitative characteristics of CPCs and plasma cell components (such as tumor cell DNA, RNA, extracellular vesicles) in patients with plasma cell disorders. Secondary Endpoint: The clonal heterogeneity and molecular characteristics of the CPCs and plasma cell components, their differences across patients, and their changes in patients followed longitudinally over time. Tertiary Objective: Correlate information from primary and secondary objectives with de-identified patient clinical data, including other routine clinical diagnostic tests, clinical management, and disease outcomes. Tertiary Endpoint: Concordance of the CPC and plasma cell components data with standard of care test results and relative sensitivity of this CPC assay for the detection of minimal residual disease (MRD). Quaternary Objective: Bank plasma cells, plasma cell components, and plasma for future analysis. Over a 5-year period, up to 21 patients per day with plasma cell disorders seen in the oncology outpatient clinic at Northwestern Memorial Hospital will undergo serial peripheral blood draws to evaluate circulating plasma cells and plasma cell components. The blood will be collected alongside routine lab tests. After the first 150-200 timepoints/samples (pilot phase) there will be a review and analysis of the data and a decision made to continue the study which will be called the extension phase. If the decision is to continue, then additional personnel will be hired, and the budget adjusted accordingly. Up to 1000 patients will be enrolled in the study.
|Effective start/end date||6/1/22 → 9/30/22|
- Menarini Silicon Biosystems, Inc. (NU 22H01)
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