ClinicalTrials.gov record NCT05283993

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study is building a cohort of people with plasma cell disorders who agree to join. It will collect clinical information, treatment and response data, and bank blood, bone marrow aspirate and urine samples before and after treatment. Scheduled assessments occur at baseline, 1, 3, 6 and 12 months after treatment and then yearly while researchers study MRD and the tumor microenvironment.

What it is studying. Whether minimal residual disease (MRD) status is related to prognosis in plasma cell disorders and how features of the tumor microenvironment (TME) are linked to disease course. It also aims to collect samples to study tumor clone selection and evolution over time.

What the researchers hope to learn. To establish a long-term cohort of patients with plasma cell disorders. To analyze the relationship between MRD status and patient outcomes. To study the role of the tumor microenvironment in disease progression. To collect and bank samples for future research on tumor clone selection and evolution; treatment responses will be measured using International Myeloma Working Group (IMWG) 2016 criteria.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • No intervention

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants have a baseline clinical and laboratory assessment and give biological samples (peripheral blood, urine, and bone marrow aspirate — the latter is an invasive needle procedure) before and after treatment; samples will be banked for future research. Clinical data and treatment responses are recorded. Follow‑up visits are scheduled at 1, 3, 6 and 12 months after treatment and then yearly. No study‑assigned treatment is given as part of this observational cohort; joining requires signing informed consent and may be limited by serious, life‑threatening comorbidities.

How the study is structured. An observational, prospective cohort study. Participants continue usual medical care; no study-assigned treatment is given. The study records clinical and laboratory data and collects blood, bone marrow aspirate and urine samples at baseline, after treatment, and at scheduled follow-ups (1, 3, 6, 12 months and then yearly). Samples will be stored for future research.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Castleman disease

Clinical trials14 trials listed for Castleman diseaseEvery trial the registry lists for Castleman disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Castleman disease researchLatest monthly update: September 2026. Includes: Unicentric tumor removal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 1, 2021
Primary completion
Dec 31, 2030 (estimated)
Study completion
Dec 31, 2030 (estimated)
Target enrollment
2000 participants (estimated)
Last updated on registry
Sep 16, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking University First Hospital
Principal investigator
Yujun DONG, chief of department of hematology
Peking University First Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Peking University First HospitalRecruiting

    Beijing · China

    • Yangliu Li

Terms used on this page · explanations by MedicalUpdates.ai

prospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
minimal residual disease
Very small amounts of disease that remain after treatment and can only be found with highly sensitive tests. 'MRD-negative' means none was detected at the test's limit. The exact test and threshold depend on the condition and the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
Follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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