Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic efficiency (reference: histopathological diagnosis)
研究概览
简要总结
This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy.
We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses.
Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm.
The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored.
Analyses of blood and tissue samples will be used to examine the disease development and biology.
Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.
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
- •Suspected ovarian neoplasm
- •Informed consent
排除标准
- •Inability to give informed consent
- •Previous ovarian cancer diagnosis
结局指标
主要结局
Diagnostic efficiency (reference: histopathological diagnosis)
时间窗: 6 months
Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.
次要结局
- Treatment response(2 years)
- Survival(5 years)
- Diagnostic efficiency of ctDNA combined with imaging (ultrasonography, MRI, PET-CT, CT, etc.) and CA 125 for differentiation of benign and malignant adnexal masses.(6 months)
- Disease stage(6 months)
- Tumour Biology(6 months)
研究者
Ina Marie Dueholm Hjorth
Medical doctor, PhD student
University of Aarhus