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

Not Applicable

Completed

Conditions: Ovarian cancer
Cancer
Malignant neoplasm of ovary

Registration Number: ISRCTN45238573

Lead Sponsor: Abbott Laboratories (Singapore)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 600

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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

Name	Time	Method
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.<br>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.<br>3. Projection of the impact of the different diagnostic algorithms' sensitivity and specificity on local healthcare costs or savings.