Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT05283993
Status:
RECRUITING
Last Update Posted:
2022-04-25
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
Sponsor:
Peking University First Hospital
Organization:
Study Overview
Official Title:
A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: