HE4 ROMA INDEX

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Tumor marker for ovarian cancer.

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HE4 ROMA INDEX - Comprehensive Medical Test Information Guide

Section 1: Why is it done?
- Test Purpose: The HE4 ROMA Index combines two tumor markers (Human Epididymis Protein 4 and CA-125) with menopausal status to assess the risk of epithelial ovarian cancer in women presenting with a pelvic mass.
- Primary Indications: Evaluating women with a known or suspected adnexal mass to determine risk stratification for ovarian cancer; differentiating benign from malignant pelvic masses; triage of patients requiring gynecologic oncology referral.
- Clinical Circumstances: Performed when a pelvic mass is identified on ultrasound or imaging; prior to surgical evaluation of suspected ovarian cancer; in women with symptoms suggestive of ovarian pathology (abdominal bloating, pelvic pain, persistent symptoms).
- Components Measured: HE4 protein levels (serum), CA-125 protein levels (serum), and menopausal status to generate a calculated risk index.
Section 2: Normal Range
- ROMA Index Values: Risk score expressed as a percentage (0-100%); interpretive categories include LOW risk (<10% for premenopausal; <6% for postmenopausal) and HIGH risk (≥10% for premenopausal; ≥6% for postmenopausal).
- Reference Ranges: Premenopausal women: ROMA <10% considered low risk; Postmenopausal women: ROMA <6% considered low risk; HE4 component: typically <70 pM/mL normal; CA-125 component: typically <35 U/mL normal.
- Result Interpretation: LOW ROMA Score indicates lower likelihood of epithelial ovarian cancer and benign etiology more probable; HIGH ROMA Score indicates elevated risk of epithelial ovarian cancer requiring further investigation and specialist referral.
- Units of Measurement: ROMA Index expressed as percentage (%), HE4 in picomoles per milliliter (pM/mL), CA-125 in units per milliliter (U/mL).
- Normal vs Abnormal: Normal (Low Risk) ROMA score suggests benign ovarian pathology or physiologic findings; Abnormal (High Risk) ROMA score warrants aggressive investigation including pelvic surgery evaluation and oncology consultation.
Section 3: Interpretation
- Low ROMA Score Interpretation: Premenopausal <10% or Postmenopausal <6% suggests benign etiology of pelvic mass; conservative management may be appropriate; follow-up imaging at intervals typically recommended; oncology consultation usually not indicated.
- High ROMA Score Interpretation: Premenopausal ≥10% or Postmenopausal ≥6% indicates elevated risk of epithelial ovarian cancer; requires urgent gynecologic oncology referral; surgical evaluation strongly recommended; imaging should not delay specialist consultation.
- Elevated HE4 and CA-125: When both markers are elevated, risk of malignancy is highest; ROMA calculation amplifies concern; immediate specialist referral warranted.
- Discordant Marker Results: When HE4 and CA-125 provide conflicting signals, ROMA algorithm integrates both with menopausal status; clinical judgment and imaging correlation essential.
- Factors Affecting Results: Renal function (affects HE4 clearance), menstrual cycle phase, endometriosis, inflammatory conditions, benign ovarian cysts, recent surgery, hepatic cirrhosis; non-ovarian malignancies may elevate CA-125.
- Clinical Significance: ROMA Index demonstrates superior discriminatory value over individual markers alone; reduces unnecessary surgical interventions for benign masses; improves triage efficiency; approximately 90% sensitivity for epithelial ovarian cancer when combined with imaging.
- Post-Menopausal vs Pre-Menopausal: Postmenopausal women have lower cutoff values due to higher baseline cancer prevalence; menopausal status significantly impacts risk stratification algorithms.
Section 4: Associated Organs
- Primary Organ System: Female reproductive system, specifically ovaries and fallopian tubes; occasionally involves peritoneum.
- Epithelial Ovarian Cancer: Most common ovarian malignancy (90% of cases); includes serous, mucinous, endometrioid, and clear cell histologies; ROMA primarily detects epithelial subtypes.
- Benign Ovarian Conditions: Functional cysts, cystadenomas, cystadenocarcinomas, fibromas, mature cystic teratomas, granulosa cell tumors, fibrothecomas.
- Gynecologic Conditions Associated with Abnormal Results: Endometriosis, uterine fibroids, endometrial cancer, tubo-ovarian abscess, severe pelvic inflammatory disease.
- Extra-Gynecologic CA-125 Elevations: Pancreatic cancer, gastric cancer, breast cancer, hepatic cancer, colonic cancer, peritoneal carcinomatosis; HE4 more specific to gynecologic malignancies.
- Potential Complications of Ovarian Cancer: Metastatic disease to peritoneum, liver, and distant organs; ascites formation; bowel obstruction; pleural effusion; venous thromboembolism.
- Renal System Involvement: Renal function significantly impacts HE4 clearance; elevated creatinine may falsely elevate HE4 levels independent of malignancy.
Section 5: Follow-up Tests
- Imaging Studies for High-Risk Results: Transvaginal ultrasound (most sensitive for adnexal masses); pelvic MRI for characterization of complex masses; CT scan for staging if malignancy confirmed; PET-CT for metastatic evaluation.
- Specialist Consultation: Urgent gynecologic oncology referral for high ROMA scores; surgical consultation for operative planning; genetic counseling if indicated for BRCA mutations.
- Tumor Marker Monitoring: Serial HE4 and CA-125 measurements post-diagnosis; baseline levels pre-chemotherapy; periodic surveillance during and after treatment; rising markers may indicate recurrence.
- Complementary Laboratory Tests: Complete blood count; comprehensive metabolic panel; liver and renal function tests; blood type and cross-match before surgery; genetic testing (BRCA1/BRCA2) for high-risk presentations.
- For Low-Risk ROMA Results: Repeat transvaginal ultrasound at 4-6 weeks; repeat ROMA at 4 weeks if ultrasound remains stable; annual follow-up; clinical reassessment if symptoms persist.
- Post-Operative Surveillance: CA-125 monitoring every 3 months for first 2 years post-diagnosis; clinical examination every 3-4 months; imaging as clinically indicated; HE4 levels may normalize after successful treatment.
- Related Biomarkers: OVA1 test (combines CA-125, HE4, prealbumin, transferrin, apolipoprotein A1); multimarker algorithms; inhibin for granulosa cell tumors; AFP for germ cell tumors.
Section 6: Fasting Required?
- Fasting Requirement: NO - Fasting is NOT required for HE4 ROMA Index testing.
- Specimen Collection: Blood sample (serum) obtained via venipuncture; standard blood draw collection tube used; no special collection requirements.
- Timing Considerations: Test can be performed any time of day; may be drawn with or without food intake; menstrual cycle phase noted but does not contraindicate testing.
- Medication Considerations: No medications need to be discontinued; hormone replacement therapy does not contraindicate testing; maintain current medication regimen unless otherwise instructed.
- Patient Preparation Instructions: No special preparation needed; patient may eat and drink normally; adequate hydration is acceptable; arrive on time for blood draw; inform staff of current medications and medical history.
- Special Circumstances: Recent surgery or biopsy does not significantly affect results; inform phlebotomist if there are difficult veins; minimal sample volume required (3-5 mL); no special tube processing needed.

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