跳至主要内容
临床试验/NCT01716728
NCT01716728Unknown不适用

Identification of Undiagnosed Lysosomal Acid Lipase Deficiency

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
number of patients with previously undiagnosed GD identified Time Frame: up to 2 years Description: Safety Issue?: No number of patients with previously undiagnosed LALD identified

研究概览

简要总结

Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups of patient who are of high clinical suspicion for undiagnosed lysosomal acid lipase deficiency. A group of potential participants will be identified through the PDR. Detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. Participants will be invited to partake in the study via a letter from their Partners care provider with supporting study details. Study participants will be evaluated in a one-time visit. A complete family and medical history will be collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All participants will be notified of their disease status via letter and phone call from the study staff. If the study participant is diagnosed with LALD through this evaluation, proper follow-up recommendations and referrals will be provided. Our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals must have records available in the Partners HealthCare Patient Data Registry

排除标准

  • Individuals must not have a diagnosis of Lysosomal Acid Lipase Deficiency

结局指标

主要结局

number of patients with previously undiagnosed GD identified Time Frame: up to 2 years Description: Safety Issue?: No number of patients with previously undiagnosed LALD identified

时间窗: up to 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Sims, MD

Neurologist

Massachusetts General Hospital

研究点 (2)

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