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 measure
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 (if study stopped)
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
Funders
Funder type
Industry
Funder name
Abbott Laboratories (Singapore)
Alternative name(s)
Abbott
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
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
Basic results (scientific)
Publication list