The Use of HE4 With Simple Ultrasound Rules to Predict Malignancy in a Pelvic Mass

Sponsor

The University of Hong Kong (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03982914

Collaborator

United Christian Hospital (Other), Pamela Youde Nethersole Eastern Hospital, Hong Kong (Other)

814

Enrollment

Locations

Anticipated Duration (Months)

271.3

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Mass

Study Design

Study Type:

Observational

Actual Enrollment :

814 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Aug 10, 2020

Anticipated Study Completion Date :

Aug 31, 2021

Outcome Measures

Primary Outcome Measures

sensitivity, specificity and predictive powers [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.

Secondary Outcome Measures

Best method for predicting malignancy in pelvic mass in HK [3 months after last subject enrolled]
The sensitivity, specificity and predictive powers for 4 different predicting methods - (i) IOTA simple rules followed by ROMA (if IOTA inconclusive), (ii) IOTA simple rules followed by expert ultrasound assessments (if IOTA inconclusive), (iii) ROMA, or (iv) RMI will be compared.
Accuracy of these 4 different prediction methods in different hospital settings [3 months after last subject enrolled]
The sensitivity, specificity and predictive powers for these 4 different prediction methods for the 3 hospitals will be compared and factors influencing the accuracy will be explored.
Performance of IOTA simple rules followed by ROMA (if IOTA inconclusive) in different histological subtypes [3 months after last subject enrolled]
Since the tumour markers assessed by ROMA may be more commonly raised in some subtypes (eg serous adenocarcinoma) compared to other subtypes (eg mucinous adenocarcinoma), it is possible that the performance of IOTA followed by ROMA may differ in different histological subtypes. The final histological subtypes will be obtained from the pathology reports from the surgery. The sensitivity and specificity of IOTA followed by ROMA will be compared amongst the different major histological subtypes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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