Longitudinal Data Registry of Plasma Cell Dyscrasia

Официальное название

Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up

Обзор

The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are: Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes? Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.

Подробное описание

PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtypes of this disease spectrum. This study is a non-interventional, real-world, multicenter study. All registered data are collected from real-world clinical practice. The medical data include patient demographics, tumor characteristics, laboratory examinations, treatment history, adverse reactions, efficacy results, and potential prognostic factors.

Первичные конечные точки

• Overall survival [Срок оценки: From the time of enrollment to data cut-off (Up to approximately 20 years).]

Вторичные конечные точки (1)

• Progression-free survival [Срок оценки: From the time of enrollment to data cut-off (Up to approximately 20 years).]

Критерии участия

Критерии включения

• Patients with pathological diagnosis of PCD \[e.g., symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis\] from 2007 to 2027 in Zhongshan Hospital or other collaborating centers.
• Patients who had complete diagnostic, treatment, and follow-up records.
• Patients with full comprehension and signature of the informed consent form (ICF) for participation.

Критерии исключения

• Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period.
• Patients who suffered from severe mental illness.
• Patients who were deemed unsuitable for inclusion by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06760052 · SHZS-PCD-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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