Natural History of Ocular GVHD
Natural History of Ocular GVHD
批准号:
8938352
负责人:
Rachel Bishop
金额:
$19.4万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
AutologousAutologous Stem Cell TransplantationBackBiological MarkersCaringCessation of lifeClinicalControl GroupsCyclosporineDataData AnalysesDatabasesDevelopmentDiagnosisDiseaseDropsDrynessEnrollmentEyedropsLiquid substanceMeasuresMedicalNatural HistoryParticipantPatientsProductionProtocols documentationReportingSamplingStem cell transplantSurfaceSymptomsTimeTravelUnited States National Institutes of Healthfollow-upgraft vs host diseasehealthy volunteerresponse
中文摘要
目前还没有关于该方案的数据报告。迄今为止,已有39名受试者入组,目前仍有31名受试者积极入组(5人死亡,2人因难以返回NIH检查而退出,1人因整体医疗负担而选择退出)。23名参与者在自体干细胞移植后完成了至少1年的随访。相当一部分患者已被建议使用局部环孢素滴眼液来应对眼部指标的变化(症状、Schirmers泪液分泌下降或表面干燥恶化)。该方案已被修订,纳入健康志愿者提供正常泪液样本,以补充我们的正常对照数据库,该数据库在2013年审查日期时被认为不足。我们的团队希望将患者症状和检查结果的变化与泪液生物标志物的变化联系起来。我们预计在下一个报告期间完成对大约25名参与者和一个类似规模的对照组的初步数据分析。
英文摘要
There are no data yet to report on this protocol. To date, 39 subjects have been enrolled, with 31 remaining actively enrolled at this time (5 lost to death, 2 withdrew due to difficulty traveling back to NIH for exams, and 1 elected to withdraw due to overall burden of medical care). 23 participants have completed at least 1 year of follow-up following autologous stem cell transplant. A significant portion of the patients have been advised to use topical cyclosporine eye drops in response to changes in ocular indicators (symptoms, drop in Schirmers tear production, or worsening of surface dryness). The protocol has been amended to include healthy volunteers to contribute normal tear fluid samples to augment our normal control data base, which was deemed inadequate at time of date review in 2013. Our team hopes to correlate changes in patient symptoms and exam findings with changes in the tear fluid biomarkers. We anticipate completing a preliminary data analysis of approximately 25 participants and a similarly sized control group by the next reporting period.
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海外基金