Clinical trial NCT05283993: A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
Official title: A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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)
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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.

Primary outcomes:
measure: A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: