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A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH

Recruiting
years of age
Both
Phase N/A

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Overview

The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.

Description

Primary

  1. To establish a prospective cohort of patients with PCDs in PKUFH.
  2. To dynamically analyze the relation between MRD status and prognosis, and the possible role of TME in PCD patients.

Secondary To collect peripheral blood, bone marrow aspirate and urine samples from PCD patients for future study, such as the tumor clone selection and evolution.

OUTLINE: PCD patients enrolled in this study will be assessed at baseline, clinical and laboratory data and biological samples be collected. Follow-up will be done at the 1, 3, 6, 12 months and then yearly after treatment.

Eligibility

Inclusion Criteria:

  1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)
  2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).
  3. Patients are included into this cohort after signing the ICFs.

Exclusion Criteria:

Significant comorbidity may be life-threatening.

Study details

Multiple Myeloma, Amyloidosis, Cryoglobulinemia, Castleman's Disease, Light Chain Deposition Disease

NCT05283993

Peking University First Hospital

25 January 2024

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