NCT06421116招募中不适用
Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Viability assessment
研究概览
简要总结
This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •More than 18 years of age;
- •Ability to understand and sign an informed consent form;
- •Clinical indication for intestinal and/or synovial biopsy;
- •Only for SpA patients group: meeting ASAS classification criteria.
排除标准
- •Actively treated cancer;
- •Severe comorbidities that, in the investigator's opinion, may affect the quality of samples for planned experimental applications;
- •Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease;
- •Only for patients undergoing a synovial biopsy: septic arthritis.
结局指标
主要结局
Viability assessment
时间窗: 24 months
The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.
次要结局
- Production of pro-inflammatory cytokines(24 months)
研究者
研究点 (1)
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