Ovarian Malignancy Risk Evaluation, ROMA algorithm

The Ovarian Cancer Risk Assessment (ROMA Algorithm) is a laboratory test designed to estimate the risk of ovarian malignancy in women with an identified ovarian or adnexal mass, or a pelvic mass.

The ROMA algorithm combines the results of the HE4 and CA 125 tumor markers with the patient's menopausal status to generate a score that classifies the risk of epithelial ovarian cancer as low or high. The result is an adjunctive assessment tool and should always be interpreted together with clinical findings, gynecological examination, and imaging studies.

Indications

• ovarian, adnexal, or pelvic mass detected clinically or by imaging;
• preoperative assessment of the risk of ovarian malignancy;
• supportive differentiation between low and high risk of malignancy;
• as part of the gynecological and imaging evaluation in premenopausal and postmenopausal women.

This test is not intended for ovarian cancer screening in asymptomatic women without documented ovarian masses.

Profile Components

• HE4 (Human Epididymis Protein 4) – a tumor marker associated with epithelial ovarian malignancies.
• CA 125 (Cancer Antigen 125) – a tumor marker used in the evaluation of ovarian pathology.
• Menopausal status (premenopausal/postmenopausal) – a required parameter for calculating the ROMA score.
• ROMA Score – a calculated index that estimates the risk of ovarian malignancy.

Method

Quantitative determination of HE4 and CA 125 tumor markers in venous blood using a validated immunoassay, followed by calculation of the ROMA score based on the obtained values and the patient's menopausal status.

Procedure

A venous blood sample is collected. After measuring the tumor marker levels, the laboratory system automatically calculates the ROMA score, and the result is reported as low risk or high risk of ovarian malignancy according to the patient's menopausal status.