NCT03982914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
814

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

January 29, 2019

Last Update Submit

June 9, 2021

Conditions

Pelvic Mass

Keywords

biomarkerHE4CA-125IOTAROMARMIpelvic massovarian cancer

Outcome Measures

Primary Outcomes (1)

  • sensitivity, specificity and predictive powers

    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.

    3 months after last subject enrolled

Secondary Outcomes (3)

  • Best method for predicting malignancy in pelvic mass in HK

    3 months after last subject enrolled

  • Accuracy of these 4 different prediction methods in different hospital settings

    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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women found to have a pelvic mass on ultrasound in Hong Kong

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

June 12, 2019

Study Start

April 1, 2018

Primary Completion

August 10, 2020

Study Completion

August 31, 2021

Last Updated

June 11, 2021

Record last verified: 2021-06

Locations

HK(3)