Longitudinal Data Registry of Plasma Cell Dyscrasia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-99
SponsorShanghai Zhongshan Hospital

About this trial

The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are:

Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes?

Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.

Eligibility criteria

Qualifiers

Patients with pathological diagnosis of PCD [e.g., symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis] from 2007 to 2027 in Zhongshan Hospital or other collaborating centers.

Patients who had complete diagnostic, treatment, and follow-up records.

Patients with full comprehension and signature of the informed consent form (ICF) for participation.

Disqualifiers

Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period.

Patients who suffered from severe mental illness.

Patients who were deemed unsuitable for inclusion by the investigator.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

Tongji Hospital

Collaborator

Peking University First Hospital

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Zhongshan Hospital Xiamen University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

Collaborator

Huzhou Central Hospital, Affiliated Central Hospital HuZhou University

Collaborator

Huadong Hospital

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator

The Third Affiliated Hospital of Nanjing Medical University

Collaborator

Peking University Shenzhen Hospital

Collaborator

Zhejiang Provincial Tongde Hospital

Collaborator

Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University

Collaborator

Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus)

Collaborator

The First Affiliated Hospital, Fujian Medical University

Collaborator

Guangdong Provincial People's Hospital

Collaborator