The Use of a New Biomarker, HE4, in Combination With Simple Ultrasound Rules in the Prediction of Malignancy in a Pelvic Mass Detected on Ultrasound
试验速览
- 阶段
- 不适用
- 入组人数
- 814
- 试验地点
- 3
- 主要终点
- sensitivity, specificity and predictive powers
研究概览
简要总结
Our objective is to determine if the combination of simple ultrasound features (IOTA simple rules) and a new biomarker (HE4) together with a common tumour marker (CA 125) can accurately predict ovarian cancer in women found to have a pelvic mass on ultrasound. The investigators hypothesize that the use of two biomarkers (HE4 and CA 125) in a mathematical algorithm (Risk of Malignancy Algorithm, ROMA) can be used to predict malignancy in a pelvic mass which has indeterminate ultrasound features. This is a prospective cohort study involving women undergoing operation for a pelvic mass. 720 women scheduled to have an operation to remove a pelvic mass would be recruited from 3 hospitals (QMH, UCH and PYNEH). Pre-operatively, each woman will have an ultrasound assessment using the IOTA simple rules criteria and have blood taken for tumour markers HE4 and CA 125. In women where IOTA ultrasound rules are inconclusive, 2 strategies for prediction will be compared - calculation of risk by ROMA (Strategy A) vs referral for an expert ultrasound (Strategy B). These pre-operative risk predictions will be correlated with the final pathology found at the operations.
Main outcome measures include the sensitivity, specificity, positive and negative predictive powers for Strategy A compared to Strategy B. Sensitivity and specificity will be compared using the McNemar test. Area Under the ROC Curve (AUC) will be calculated and compared using the Delong method for the 2 strategies.
The investigators expect AUC of both strategies will be similar. This would suggest that ROMA can replace expert ultrasound in the pre-operative prediction of ovarian cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Women over the age of 18
- •Found to have a pelvic mass on ultrasound, MRI, CT or PET scan
- •Scheduled for operation (laparoscopic or open) for a pelvic mass (including ovarian cystectomy and oophorectomy)
- •Women who would understand the informed consent
排除标准
- •Women who refused a transvaginal scan
- •Pregnant women
- •Surgical removal is delayed for more than 120 days from the date of the ultrasound examination
- •Previous history of ovarian, peritoneal or fallopian tube cancer or unknown malignancy
- •History of bilateral oophorectomy
结局指标
主要结局
sensitivity, specificity and predictive powers
时间窗: 3 months after last subject enrolled
The group of women with inconclusive IOTA assessment will undergo further assessment by both tumour markers assessment by ROMA (Strategy A) and expert ultrasound (Strategy B). The prediction of risk of malignancy (high or low) will be correlated with the final histopathology result from the surgery. The sensitivity, specificity and predictive powers for the 2 strategies will be compared.
次要结局
- Accuracy of these 4 different prediction methods in different hospital settings(3 months after last subject enrolled)
- Best method for predicting malignancy in pelvic mass in HK(3 months after last subject enrolled)
- Performance of IOTA simple rules followed by ROMA (if IOTA inconclusive) in different histological subtypes(3 months after last subject enrolled)