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

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ClinicalTrials.gov Identifier: NCT05283993
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Yujun DONG, Peking University First Hospital

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.

Condition or disease Intervention/treatment
Multiple Myeloma Amyloidosis Cryoglobulinemia Castleman's Disease Light Chain Deposition Disease Heavy Chain Deposition Disease Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes Smoldering Multiple Myeloma Plasma Cell Leukemia Monoclonal Gammopathy of Undetermined Significance (MGUS) Monoclonal Gammopathy of Renal Significance (MGRS) Monoclonal Gammopathy of Neurological Significance (MGNS) Other: No intervention

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030



Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH [ Time Frame: 10 years ]
    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.


Biospecimen Retention:   Samples With DNA
Peripheral blood, bone marrow aspirate and urine samples will be banked for future research involving adults with PCDs.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Hospitalized patients with confirmed diagnosis of PCDs will be enrolled. 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).
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283993


Contacts
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Contact: Bo Tang, PhD 008613521776195 tangbo8809@163.com
Contact: Yujun Dong, M.D. 008618210264969 dongy@hsc.pku.edu.cn

Locations
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China
Peking University First Hospital Recruiting
Beijing, China
Contact: Yangliu Li         
Sponsors and Collaborators
Peking University First Hospital
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Responsible Party: Yujun DONG, chief of department of hematology, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT05283993    
Other Study ID Numbers: PekingUFHH
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Leukemia, Plasma Cell
Polyneuropathies
POEMS Syndrome
Cryoglobulinemia
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Castleman Disease
Amyloidosis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hypergammaglobulinemia
Precancerous Conditions
Lymphatic Diseases