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

Sponsor

Peking University First Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05283993

Collaborator

(none)

2,000

Enrollment

Location

114

Anticipated Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Amyloidosis Cryoglobulinemia Castleman's Disease Light Chain Deposition Disease Heavy Chain Deposition Disease Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes Smoldering Multiple Myeloma Plasma Cell Leukemia Monoclonal Gammopathy of Undetermined Significance (MGUS) Monoclonal Gammopathy of Renal Significance (MGRS) Monoclonal Gammopathy of Neurological Significance (MGNS)	Other: No intervention

Detailed Description

Primary

To establish a prospective cohort of patients with PCDs in PKUFH.
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Outcome Measures

Primary Outcome Measures

A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH [10 years]
To 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.