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NCT05283993 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05283993
Other study ID # PekingUFHH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2030

Study information
Verified date April 2022
Source Peking University First Hospital
Contact Bo Tang, PhD
Phone 008613521776195
Email tangbo8809@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
China Peking University First Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH 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. 10 years
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