Pediatrics Epidemiology Center, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
Diabetes Metab Res Rev. 2013 Oct;29(7):557-67. doi: 10.1002/dmrr.2427.
The vast array and quantity of longitudinal samples collected in The Environmental Determinants of Diabetes in the Young study present a series of challenges in terms of quality control procedures and data validity. To address this, pilot studies have been conducted to standardize and enhance both biospecimen collection and sample obtainment in terms of autoantibody collection, stool sample preservation, RNA, biomarker stability, metabolic biomarkers and T-cell viability.
The Environmental Determinants of Diabetes in the Young is a multicentre, international prospective study (n = 8677) designed to identify environmental triggers of type 1 diabetes (T1D) in genetically at-risk children from ages 3 months until 15 years. The study is conducted through six primary clinical centres located in four countries.
As of May 2012, over three million biological samples and 250 million total data points have been collected, which will be analysed to assess autoimmunity status, presence of inflammatory biomarkers, genetic factors, exposure to infectious agents, dietary biomarkers and other potentially important environmental exposures in relation to autoimmunity and progression to T1D.
Detailed procedures were utilized to standardize both data harmonization and management when handling a large quantity of longitudinal samples obtained from multiple locations. In addition, a description of the available specimens is provided that serve as an invaluable repository for the elucidation of determinants in T1D focusing on autoantibody concordance and harmonization, transglutaminase autoantibody, inflammatory biomarkers (T-cells), genetic proficiency testing, RNA lab internal quality control testing, infectious agents (monitoring cross-contamination, virus preservation and nasal swab collection validity) and HbA1c testing.
在“儿童期糖尿病的环境决定因素”研究中，收集了大量的纵向样本，这在质量控制程序和数据有效性方面带来了一系列挑战。为此，已经进行了试点研究，以规范和增强自动抗体收集、粪便样本保存、RNA、生物标志物稳定性、代谢生物标志物和 T 细胞活力方面的生物样本收集和样本获取。
“儿童期糖尿病的环境决定因素”是一项多中心、国际前瞻性研究（n=8677），旨在确定遗传易感儿童从 3 个月到 15 岁期间发生 1 型糖尿病（T1D）的环境触发因素。该研究通过位于四个国家的六个主要临床中心进行。
截至 2012 年 5 月，已经收集了超过 300 万份生物样本和 2.5 亿个总数据点，这些样本将进行分析，以评估自身免疫状态、炎症生物标志物、遗传因素、感染因子暴露、饮食生物标志物和其他与自身免疫和 T1D 进展相关的潜在重要环境暴露情况。
在处理来自多个地点的大量纵向样本时，详细的程序被用来规范数据的协调和管理。此外，还提供了可用样本的描述，这些样本为阐明 T1D 中的决定因素提供了宝贵的资源，重点是自身抗体一致性和协调、转谷氨酰胺酶自身抗体、炎症生物标志物（T 细胞）、遗传能力测试、RNA 实验室内部质量控制测试、感染因子（监测交叉污染、病毒保存和鼻拭子收集有效性）和 HbA1c 测试。
