The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study

Официальное название

The China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) --A Multicenter Observational Study

Обзор

The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with multiple myeloma in China population, and establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple myeloma. We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

Подробное описание

The CHAPERONE study aims to assess the clinical significance of screening for monoclonal gammopathy in first-degree relatives of patients with multiple myeloma in China.

The main objectives it aims to answer are:

* Main research objectives: To study the prevalence of MGUS, the time of disease progression, and its influencing factors in first-degree relatives of multiple myeloma patients in China. * Secondary study objective: To explore the clinical/genomic/epigenetic features, survival, and quality of life of MGUS patients in first-degree relatives of multiple myeloma patients in China.

All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests, and patients with MGUS will be carefully assessed and followed up.

Вмешательства

• Диагностический тест Sample of Blood
  All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests to determine their accurate diagnosis. Patients with monoclonal gammopathy of undetermined significance (MGUS) would be carefully assessed and followed up.

Первичные конечные точки

• The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives [Срок оценки: 2 Years]
• Time to progression (TTP) from MGUS to overt multiple myeloma [Срок оценки: 10 Years]

Вторичные конечные точки (2)

• Overall survival of MGUS patients [Срок оценки: 10 Years]
• Quality of life (QoL) of MGUS patients [Срок оценки: 10 Years]

Критерии участия

Критерии включения

• Male or female over the age of 18;
• First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria;
• Understand the purpose and procedure of this trial and voluntarily participate in this screening study;
• Participants should be willing and able to follow the study follow-up plan and other protocol requirements.

Критерии исключения

Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma (SMM), or multiple myeloma

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

Публикации

• Li J, Wang Y, Liu P. The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. J Cancer. 2019 Aug 27;10(20):4807-4813. doi: 10.7150/jca.32103. eCollection 2019. PMID 31598151

Идентификаторы

NCT: NCT05965115 · CHAPERONE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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