A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Amyloidosis, Cryoglobulinemia, Castleman's Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH
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.
Detailed 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.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)
- 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).
- Patients are included into this cohort after signing the ICFs.
Exclusion criteria
Significant comorbidity may be life-threatening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT05283993 · PekingUFHH