Evaluation of HE4 and CA125 serum markers to improve the risk determination of ovarian cancer in Malaysian women

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN45238573

Enrollment

600

Registered

2014-04-04

Start date

2014-07-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer Cancer Malignant neoplasm of ovary

Interventions

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.

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026