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

NCT03982914 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 814

Last updated 2021-06-11

No results posted yet for this study

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.

Conditions

  • Pelvic Mass

Sponsors & Collaborators

  • United Christian Hospital

    collaborator OTHER

  • Pamela Youde Nethersole Eastern Hospital, Hong Kong

    collaborator UNKNOWN

  • The University of Hong Kong

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2020-08-10
Completion
2021-08-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982914 on ClinicalTrials.gov