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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with pathological diagnosis of PCD from 2007 to 2027 according to 2016 WHO classification.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: Enrolled patients
Trial outcomes
Primary outcomes
1
Overall survival
Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause.
Time frame
From the time of enrollment to data cut-off (Up to approximately 20 years).Secondary outcomes
1
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death of any cause, whichever occurs first.
Time frame
From the time of enrollment to data cut-off (Up to approximately 20 years).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov