Pelvic MassNCT03982914
The Use of HE4 With Simple Ultrasound Rules to Predict Malignancy in a Pelvic Mass
An observational study of Pelvic Mass, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Mass
- How many people
- 814 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Apr 2018to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women found to have a pelvic mass on ultrasound in Hong Kong
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
United Christian Hospital
Hong Kong
About this study
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
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
- Keywords
- biomarker, HE4, CA-125, IOTA, ROMA, RMI, pelvic mass, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after last subject enrolled
Secondary outcomes (3)
Best method for predicting malignancy in pelvic mass in HK
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.
Measured: 3 months after last subject enrolled
Accuracy of these 4 different prediction methods in different hospital settings
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.
Measured: 3 months after last subject enrolled
Performance of IOTA simple rules followed by ROMA (if IOTA inconclusive) in different histological subtypes
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.
Measured: 3 months after last subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Apr 2018
- Primary completion10 Aug 2020
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic MassStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital, Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982914
- Sponsor's protocol ID
- UW 17-551
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03982914
- Acronym / sponsor ID
- UW 17-551
- Conditions
- Pelvic Mass
- Keywords
- biomarker, HE4, CA-125, IOTA, ROMA, RMI, pelvic mass, ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 814 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- United Christian Hospital, Pamela Youde Nethersole Eastern Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women found to have a pelvic mass on ultrasound in Hong Kong
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity, specificity and predictive powers
Time frame: 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.
3 secondary outcomes
Best method for predicting malignancy in pelvic mass in HK
Time frame: 3 months after last subject enrolled
Accuracy of these 4 different prediction methods in different hospital settings
Time frame: 3 months after last subject enrolled
Performance of IOTA simple rules followed by ROMA (if IOTA inconclusive) in different histological subtypes
Time frame: 3 months after last subject enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Mass, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity and predictive powers (time frame: 3 months after last subject enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.