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临床试验 NCT07347834 (TRIOCOL) 针对溃疡性结肠炎 (UC)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis 500
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临床试验NCT07347834 (TRIOCOL)是一项针对溃疡性结肠炎 (UC)的观察研究试验，目前试验状态为招募中。试验始于2024年10月22日，计划招募500名患者。该研究由Region Stockholm主导，预计于2038年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月21日。
简要概括
Ulcerative colitis is an inflammatory disease affecting the rectum and colon, most commonly presenting in late adolescence or early adulthood. The primary treatment approach is pharmacological. Over the past two decades, there has been significant progress in the development of so-called advanced medical therapies, and new drugs in this category continue to emerge. These medications are highly effective for many pati...显示更多
官方标题
TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis
疾病
溃疡性结肠炎 (UC)其他研究标识符
- TRIOCOL
- KI 4-3290/2024
NCT编号
实际开始日期
2024-10-22
最近更新发布
2026-01-21
预计完成日期
2038-12
计划入组人数
500
研究类型
观察研究
试验状态
招募中
关键词
Ulcerative colitis
Advanced medical therapy
Colectomy
Health related quality of life
Shared decision-making
Advanced medical therapy
Colectomy
Health related quality of life
Shared decision-making
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Contunued advanced medical therapy If the patient chooses continued medical therapy, the gastroenterologist evaluates the patient for a new line of AMT in accordance with clinical practice. The study period starts on the date of initiation of the new drug. | 不适用 |
Colectomy If the patient chooses colectomy the surgeon will inform the patient further, schedule the surgery, and if needed commence with preoperative optimization in accordance with standard clinical practice. The study period starts at the date of surgery. | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
HRQoL at six months | The patients will be evaluated with electronically distributed questionnaires at six months. The primary endpoint, health related quality of life (HRQOL), will be evaluated with 36-Item Short Form Survey (SF-36). Range 0-100. Higher number indicated better HRQOL. | Primary endpoint evaluated six months after enrollement. |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Patients with UC with active disease
- failed at least two lines of advanced medical therapies
- are eligible for both continued AMT and colectomy
- diagnostic uncertainty
- diagnosis of impaired cognitive function
- non-domestic and non-English speaking
Region Stockholm研究中心联系人
联系人: Carl Kördel, MD, PhD-student, +46702545871, [email protected]
1 位于 1 个国家/地区的研究中心
Stockholm County
Karolinska University Hospital, Solna, Stockholm County, 17176, Sweden
Carl Kördel, MD, PhD-student, 联系人, +46702545871, [email protected]
招募中