Condition category
Cancer
Date applied
12/03/2014
Date assigned
04/04/2014
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The poor survival rate in ovarian cancer is partly due to the lack of effective screening and also due to lack of symptoms in the early stage of the disease. Presence of the component CA125 in blood is the most widely used biomarker in ovarian cancer; however, it is not always increased in patients. The marker HE4 was best for detecting early stage ovarian cancer, and a combination of CA125 and HE4 provided a more accurate predictor of ovarian cancer than either marker alone. The purpose of this study is to evaluate the performance of HE4 alone and in combination with CA125 in Malaysian women to better predict malignant ovarian cancer in women presenting with a lump in the uterus (adnexal mass).

Who can participate?
Selected women who will undergo surgery for an adnexal mass will be enrolled for this study.

What does the study involve?
Each participant will give a blood sample before and after surgery, and a tissue sample taken during the surgery. Blood samples collected before surgery will be tested at the end of the patient enrolment. Clinical information such as age, menopausal status, risk factors for ovarian cancer, type of benign or malignant disease, and type and stage of cancer will be collected. For patients confirmed with diagnosis of ovarian cancer, a blood sample will be collected on a post-surgery follow-up visit and tested at the UMMC laboratory.

What are the possible benefits and risks of participating?
There is no immediate benefit from participating in the study; routine follow-up will be provided for those women diagnosed with and treated for malignant ovarian cancer. Future benefits to women with adnexal masses could be possible if the study the results show improved estimation of the risk of ovarian cancer, leading to a change in the diagnostic guidelines. No risk to participants are expected.

Where is the study run from?
This study will be conducted at University of Malaya Medical Centre (UMMC), in collaboration with Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Universiti Putra Malaysia (UPM) and Hospital Universiti Sains Malaysia (HUSM) for patient enrolment.

When is the study starting and how long is it expected to run for?
Recruitment of participants will happen over a period of 6 - 9 months, starting from July 2014. The study will end in December 2014.

Who is funding the study?
Abbott Laboratories (Singapore)

Who is the main contact?
Professor Noor Azmi Adenan
azmie@um.edu.my

Trial website

Contact information

Type

Scientific

Primary contact

Prof Noor Azmi Adenan

ORCID ID

Contact details

Department of O&G/Gynae Oncology
Faculty of Medicine
University of Malaya
7th floor
Maternal and Child Health Complex
University of Malaysia Medical Center
Lembah Pantai
Kuala Lumpur
50603
Malaysia
379492049
azmie@um.edu.my

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14-03-MYHE4

Study information

Scientific title

HE4/ROMA (Risk of Ovarian Malignancy Algorithm) Evaluation Study in Malaysian Women

Acronym

Study hypothesis

The measurement of HE4 in combination with CA125 in Malaysia women could improve the sensitivity and/or specificity for predicting malignant ovarian cancer in women presenting with an adnexal mass.

The null hypothesis is the HE4 serum marker and Risk of Ovarian Malignancy Algorithm (ROMA) adds no value to the current CA125 screening assay in women with an adnexal mass.

Ethics approval

Medical Ethics Committee Composition, University of Malaya Medical Centre, 23/04/2014

Study design

Blinded observational multi-center study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ovarian cancer

Intervention

All women in this study will undergo surgery for their adnexal mass and the diagnosis will be based upon the final histopathological findings and stage according to FIGO (2009) classification.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To evaluate ARCHITECT HE4/CA125 and ROMA values, measured at baseline, in estimating the risk of ovarian cancer in pre- and post-menopausal Malaysian women presenting with an adnexal mass.
2. To evaluate the performance of ARCHITECT HE4/CA125 and ROMA, measured at baseline, in discriminating benign and malignant pathologies in comparison to the ACOG/SGO pelvic mass referral guidelines in women with an adnexal mass.

Secondary outcome measures

1. Correlation of ARCHITECT HE4, ARCHITECT CA125, and ROMA values, collected at baseline, to the type and stages of malignancy in epithelial and mucinous ovarian cancers in samples.
2. Evaluation of the different combinations of guideline criteria collected at baseline to determine the best criteria for surgical referral of women with detected adnexal mass.
3. Projection of the impact of the different diagnostic algorithms' sensitivity and specificity on local healthcare costs or savings.

Overall trial start date

15/04/2014

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Malaysian females consenting to undergo surgery based on the finding of adnexal mass.
2. Adnexal mass must be verified by imaging.
3. Presence of at least one of the ACOG/SCO guideline criteria.
4. Able to understand and sign the Informed Consent forms. For females <18 years old, consent will be obtained from their parents or guardian.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Minimum 400, maximum 600

Participant exclusion criteria

1. Previous history of ovarian or primary peritoneal cancer
2. Subject previously confirmed with endometriosis
3. Any women with any known active malignancy
4. Subjects with previous bilateral oophorectomy
5. Subjects known to be pregnant
6. Subjects with end-stage renal failure
7. Subjects who previously underwent an organ transplantation

Recruitment start date

01/07/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Malaysia

Trial participating centre

University of Malaysia Medical Center
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

Abbott Laboratories (Singapore)

Sponsor details

c/o Carlum Shiu
103 Penang Road #03-01
VisionCrest Commercial
Singapore
238467
Singapore

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Laboratories (Singapore)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added.