Clinical trial NCT03982914: The Use of HE4 With Simple Ultrasound Rules to Predict Malignancy in a Pelvic Mass
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Mass
Keywords: biomarker
HE4
CA-125
IOTA
ROMA
RMI
pelvic mass
ovarian cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: United Christian Hospital
name: Pamela Youde Nethersole Eastern Hospital, Hong Kong
First posted: 2019-06-12
Enrollment: 814
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women found to have a pelvic mass on ultrasound in Hong Kong

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.


Eligibility criteria: 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

Primary outcomes:
measure: sensitivity, specificity and predictive powers
timeFrame: 3 months after last subject enrolled
Secondary outcomes:
measure: Best method for predicting malignancy in pelvic mass in HK
timeFrame: 3 months after last subject enrolled
measure: Accuracy of these 4 different prediction methods in different hospital settings
timeFrame: 3 months after last subject enrolled
measure: Performance of IOTA simple rules followed by ROMA (if IOTA inconclusive) in different histological subtypes
timeFrame: 3 months after last subject enrolled
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
References: