Cohort of patients with plasma cell disorders at Peking University First Hospital
A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH
This study is looking at hospitalized patients with plasma cell disorders to see how their treatment and disease status affect their outcomes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05283993 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a prospective cohort of hospitalized patients diagnosed with plasma cell disorders (PCDs) at Peking University First Hospital. It will collect clinical characteristics, treatment options, and responses, along with biological samples such as peripheral blood, bone marrow aspirate, and urine for future research. The study will focus on analyzing the correlation between minimal residual disease (MRD) status and prognosis, as well as the role of the tumor microenvironment (TME) in the pathogenesis and progression of PCDs. Follow-up assessments will occur at various intervals post-treatment to monitor patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include hospitalized patients with confirmed diagnoses of plasma cell disorders such as multiple myeloma, amyloidosis, and cryoglobulinemia.
Not a fit: Patients with significant comorbidities that may be life-threatening may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of plasma cell disorders and improve patient management and treatment outcomes.
How similar studies have performed: While similar cohort studies have been conducted, this specific approach focusing on the tumor microenvironment and MRD status in PCDs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Bo Tang, PhD
- Email: tangbo8809@163.com
- Phone: 008613521776195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.