临床试验/NCT05919511

NCT05919511招募中不适用

A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)

Incyte Corporation56 个研究点分布在 1 个国家目标入组 1,500 人开始时间: 2023年8月1日最近更新: 2026年8月25日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Incyte Corporation
入组人数: 1,500
试验地点: 56
主要终点: Overall Burden of cGVHD diagnosis and severity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years inclusive at the time of signing the ICF
•Allogeneic SCT 90 to 180 days prior to enrollment
•Able to comprehend and willing to provide informed consent
•Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel

排除标准

•There are no exclusion criteria for this study

结局指标

主要结局

Overall Burden of cGVHD diagnosis and severity

时间窗: 36 months

次要结局

To describe personal and healthcare resources associated with the management of cGVHD(36 months)
To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD(Up to 36 months)

研究者

发起方

Incyte Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (56)

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