Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05283993
Enrollment
2000
Registered
2022-03-17
Start date
2021-07-01
Completion date
2030-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis, Castleman's Disease, Cryoglobulinemia, Heavy Chain Deposition Disease, Light Chain Deposition Disease, Monoclonal Gammopathy of Neurological Significance (MGNS), Monoclonal Gammopathy of Renal Significance (MGRS), Monoclonal Gammopathy of Undetermined Significance (MGUS), Multiple Myeloma, Plasma Cell Leukemia, Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes, Smoldering Multiple Myeloma

Brief summary

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

OTHERNo intervention

No intervention

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH10 yearsTo measure the treatment response in the cohort study of PCDs in PKUFH.The treatment response is done according to the criteria of the International Myeloma Working Group (IWMG) of 2016.

Countries

China

Contacts

CONTACTBo Tang, PhD
tangbo8809@163.com008613521776195
CONTACTYujun Dong, M.D.
dongy@hsc.pku.edu.cn008618210264969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026