Impact of Immunosuppressive Therapy of Sarcoidosis on Lymphoma Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome will be incident, biopsy-proven lymphoma during the 12-month follow-up.
研究概览
简要总结
Impact of Immunosuppressive Therapy for Sarcoidosis on Lymphoma Development
详细描述
This is a prospective observational cohort study to be conducted in the Chest Diseases Department, Alexandria Main University Hospital. A total of 40 adult patients (≥16 years) with biopsy-proven sarcoidosis will be consecutively recruited between December 2024 and December 2025. All patients will be either newly starting or continuing immunosuppressive therapy for sarcoidosis. The treatment regimen-systemic corticosteroids, conventional steroid-sparing agents (methotrexate, azathioprine, or mycophenolate), or biologics (anti-TNF agents)-will be recorded but not altered by study design. Each patient will be followed prospectively for 12 months from enrollment.
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
- 是
入选标准
- •Inclusion criteria include adult patients (≥18 years) with histologically confirmed sarcoidosis, receiving or planned to receive immunosuppressive therapy
排除标准
- •Patients with a prior history of lymphoma or other active malignancy, HIV infection, or other primary immunodeficiency will be excluded.
结局指标
主要结局
The primary outcome will be incident, biopsy-proven lymphoma during the 12-month follow-up.
时间窗: 12 MONTHS
LYMPH NODE BIOPSY EITHER EXCISIONAL OR BRONCHOSCOPIC
lymphoma development
时间窗: 12 months
lymph node biopsy excisional or bronchoscopic
次要结局
未报告次要终点
研究者
Mohamed Sabry
lecturer
Alexandria University