Dry Blood Spot Screening Test for Biliary Atresia(DBS-SCReBA)
Dry Blood Spot Screening Test for Biliary Atresia and Other Cholestasis Diseases
研究概览
详细说明
BA accounts for approximately 60% of the liver transplantations in infants younger than 1 year of age. The diagnosis of BA remains a clinical challenge because affected neonates have signs, symptoms, and serum liver biochemistry that are also seen in those with other causes of neonatal cholestasis.
The success of the Kasai procedure is varied, but a good outcome is correlated with an early diagnosis. Unfortunately, most BA are usually identified later and the average age at surgery is about 60 days. To address this problem, some research groups screen infants for the pale stools or measure bilirubin level in the serum. However, these screening programs have not yet to be implemented because of several reasons. Recently, the relative abundance of serum MMP-7 was suggested to have discriminatory features for infants with BA. Nevertheless, whether the level of MMP-7 elevates in newborn dry blood spot of BA is still undefined. In this study, we will explore a screening strategy based on DB, γ-GT or MMP-7 measurement in newborn screening blood spot, and identify whether DB , γ-GT or MMP-7 measurement in the newborn period could be sensitive and specific for BA.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Shanghai、中国
- Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Neonates born in Shanghai
Exclusion Criteria:
- Subjects who do not agree with study protocol
- Subjects who join other clinical trials
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Experimental:Dry blood spot screening
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Dry blood spot measurement of biomarker for screening biliary atresia
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Suspected BA
大体时间:Three to Seven days after birth
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MMP-7 with or without other one or two biomarkers (DB and γ-GT) > upper limit of normal value
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Three to Seven days after birth
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合作者和调查者
调查人员
- 研究主任:Wei Cai, Pro、Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- XH-BA-1
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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