ROMA index (Risk of Ovarian Malignancy Algorithm) is a comprehensive study designed to stratify the risk of epithelial ovarian cancer in women with detected pelvic masses.

CA-125 alone often gives false-positive results in endometriosis, cysts, or pelvic inflammatory disease, and may also remain normal in the early stages of cancer. Adding a highly sensitive marker HE4 and the use of a mathematical calculation algorithm taking into account hormonal status (pre- or postmenopause) significantly increases the accuracy, sensitivity, and specificity of diagnosis.

What is this study for?

Malignancy assessment: Determining the probability that a detected formation (cyst, tumor) in the ovary is malignant.
Early diagnosis: Detection of epithelial ovarian cancer in the initial (I–II) stages.
Patient routing: Assisting the gynecologist in making a decision to refer the patient for consultation or surgical treatment to a specialized gynecological oncologist.
Treatment monitoring: Assessment of the effectiveness of the therapy and detection of relapses in patients with an established diagnosis.

Who is recommended to take the test?

Women who have ovarian masses (cysts, tumors) detected during an ultrasound, CT scan, or MRI of the pelvic organs.
Women with symptoms that may indicate ovarian pathology (lower abdominal pain, abdominal distension, bloating, urinary incontinence).
Patients with a high family risk of ovarian or breast cancer.
For dynamic monitoring after surgical or medical treatment of ovarian cancer.

Preparation for the study

On an empty stomach: Blood is donated in the morning on an empty stomach (after 8–12 hours of fasting). It is allowed to drink clean, non-carbonated water.
Diet in 24 hours: The day before, avoid fatty foods, alcohol, and overeating.
Physical and emotional peace: Limit intense training, heavy physical labor, and stressful situations the day before blood collection.
Smoking: Do not smoke 1–2 hours before the procedure.
Important note: For the algorithm to calculate accurately, it is necessary to specify the woman's menstrual status (premenopause or postmenopause).

What do the results mean? (Interpretation)

The result is given in the form of three indicators: concentration CA-125, concentration HE4 and final settlement ROMA Index value (%).

Premenopause (women of reproductive age):
- ROMA < 11.4%: Low risk of detecting epithelial ovarian cancer.
- ROMA ≥ 11.4%: High risk of detecting a malignant neoplasm.
Postmenopause:
- ROMA < 29.9%: Low risk of detecting epithelial ovarian cancer.
- ROMA ≥ 29.9%: High risk of detecting a malignant neoplasm.

Note: Obtaining a high ROMA value indicates the need for an in-depth oncogynecological examination, but is not a definitive diagnosis without histological confirmation.

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