2177GCCC: Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease (oGVHD) a Biobank Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1. Risk factors and markers for developing eye diseases
研究概览
简要总结
Evaluate and study the immunologic changes to the ocular surface in cancer patients.
详细描述
This is a longitudinal natural history study to evaluate and study the immunologic changes to the ocular surface in cancer patients.
Two groups of subjects will be recruited for the study: 1) Pre-bone marrow transplant cancer patients. They will be evaluated every 3 months for 2 years.2) Normal control patients. They will be evaluated every 6 months for the duration of the study.
During each study visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments, or impression cytology of conjunctiva, blood, or serum) will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Adult patients (≥ 18 years of age) who visit the Eye clinic either in the UMGCCC within the UMD Hospital or the UMD Faculty Physicians Ophthalmology Practice at the UMD Professional Building or satellite locations for initial visits or established visits.
- •The patient must be able to understand and sign and date the informed consent form approved by the IRB.
排除标准
- •Vulnerable populations: neonates, children, prisoners, institutionalized individuals.
- •Inability or refusal to provide informed consent.
- •History of ocular surgery (except refractive surgery or cataract surgery)
研究组 & 干预措施
1.BMT Patients (Study)
Patients prior to receiving a bone marrow transplant will be recruited during their initial intake prior to their BM transplant through the PI's regularly scheduled appointment with these patients.
干预措施: The standard care exam and biological specimens' collection (Diagnostic Test)
2.Controls
Patients with no history of eye disease or cancer history
干预措施: The standard care exam and biological specimens' collection (Diagnostic Test)
结局指标
主要结局
1. Risk factors and markers for developing eye diseases
时间窗: Up to 4 years
Number of patients with the risks and markers who have developed the eye diseases during the study
2. The mechanisms of eye damage
时间窗: Up to 4 years
Number of patients who have eye damage during the study
The drug acting targets
时间窗: Up to 4 years
Number of patients who have eye diseases with eye surface changes after the treatment during the study.
The effect of ocular Graft-vs-Host Disease on the eye
时间窗: Up to 4 years
Number of patients who have eye surface changes with Graft-vs-Host Disease during the study
次要结局
未报告次要终点