A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.
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- Состояния в реестре: Multiple Myeloma, M Protein. Базовые параметры: от 18 лет · Все.
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Официальное название
A Cross-sectional Study on the Positive Rate of Monoclonal Immunoglobulin (M Protein) in the Serum of Patients Seeking Medical Treatment in Tertiary Hospitals Based on a Highly Sensitive Serum M Protein Detection Method.
Обзор
By using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments. And exploring the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.
Подробное описание
Monoclonal gammopathy (MG) is an asymptomatic pre-cancerous clonal proliferation of plasma cells. The onset of this disease is concealed, usually discovered by chance by patients who undergo protein electrophoresis to detect monoclonal gamma globulin (M protein) due to various clinical symptoms and disease evaluations. Due to the insidious onset of monoclonal immunoglobulin, involving multiple organs, and the non-specific clinical symptoms, it is more prone to misdiagnosis. This study hypothesized that among patients who first came to the hospital for treatment, some patients had elevated serum monoclonal immunoglobulin levels but were not initially diagnosed with hematology department, but instead sought medical attention from other departments due to other symptoms. In this study，by using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments，and to explore the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.
Первичные конечные точки
- Positive rate of M protein [Срок оценки: one year]
- The distribution of positive rate of M protein in different departments [Срок оценки: one year]
Вторичные конечные точки (1)
- Correlation analysis [Срок оценки: one year]
Критерии участия
Критерии включения
- Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital;
- Age: over 18 years old;
- There are sufficient remaining serum samples and extensive informed consent has been signed.
Критерии исключения
- Early diagnosis of hematological diseases such as plasma cell or other B lymphocyte proliferative diseases；
- Improper storage or repeated freeze-thaw of remaining serum samples.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Китай · 1 центр
- Zhujiang Hospital of Southern Medical University — Гуанчжоу
Идентификаторы
NCT: NCT06082284 · Zhujiangzny