Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 684
- 试验地点
- 1
- 主要终点
- Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis
研究概览
简要总结
This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal population in the western region of Sweden. The aim is to improve diagnosis of ovarian cancer.
If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
详细描述
The investigators are currently using CA125 and RMI in diagnosing patients with a pelvic cyst/tumor and referring them to tertiary centers for surgery in the western region of Sweden. The diagnostic accuracy is unsatisfying why the investigators are evaluating HE4 and ROMA as a complement, in combination or separately to improve diagnostic accuracy.
The trial is based on a normal population cohort of patients included at all the hospitals in the region. The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.
If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age, understand spoken and written Swedish information, admitted for surgery for a cyst/tumos in the pelvis
排除标准
- •Rejected participation, cytotoxic chemotherapy prior to surgery, rejected surgery, serum sample failure, already included at another hospital
结局指标
主要结局
Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis
时间窗: 12 months
Finding the true cases and avoiding unnecessary surgery, a descriptive analysis of a normalpopulation
次要结局
- Improve triage of patients to tertiary centers for surgery(12 months)
研究者
Karin Sundfeldt
Professor
Göteborg University