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NCT Number: NCT05283993

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

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.

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Key information

Conditions

Multiple Myeloma Abnormalities, Multiple Amyloidosis Blood Protein Disorders Cardiovascular Diseases Castleman Disease Castleman's Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryoglobulinemia Heavy Chain Deposition Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Plasma Cell Light Chain Deposition Disease Lymphatic Diseases Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Neurological Significance (MGNS) Monoclonal Gammopathy of Renal Significance (MGRS) Monoclonal Gammopathy of Undetermined Significance Monoclonal Gammopathy of Undetermined Significance (MGUS) Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases POEMS Syndrome Paraproteinemias Peripheral Nervous System Diseases Plasma Cell Leukemia Polyneuropathies Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes Precancerous Conditions Proteostasis Deficiencies Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Smoldering Multiple Myeloma Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, China

Location status: Recruiting

Location contact

Yangliu Li

CONTACT

About this study

Primary

To establish a prospective cohort of patients with PCDs in PKUFH.
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)
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).
Patients are included into this cohort after signing the ICFs.

Exclusion criteria

Significant comorbidity may be life-threatening.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Tang, PhD

CONTACT

[email protected]

008613521776195

Yujun Dong, M.D.

CONTACT

[email protected]

008618210264969

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2030
Study completion: 2030
First posted: Mar 17, 2022
Registry last updated: Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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