Ann Lab Med.  2019 May;39(3):252-262. 10.3343/alm.2019.39.3.252.

Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Clinical Practice at a Single Hospital in Korea

• Park H
• Shin JE
• Lee DW
• Kim MJ
• Lee HN

• KMID: 2431602
• DOI: http://doi.org/10.3343/alm.2019.39.3.252

Abstract

BACKGROUND
The risk of ovarian malignancy algorithm (ROMA) is used for assessing ovarian cancer risk in women with a pelvic mass. Its diagnostic accuracy is variable. We investigated whether the clinically acceptable minimal sensitivity of >80.0% could be obtained with the suggested cutoff of 7.4%/25.3% for pre/postmenopausal women and with adjusted cutoffs set to a specificity of ≥75.0% or a sensitivity of 95.0%, in a hospital with a lower ovarian cancer (OC) prevalence than previously reported.
METHODS
ROMA scores were calculated from measurements of human epididymis protein 4 and cancer antigen 125 in blood specimens from 443 patients with a pelvic mass. The ROMA-based risk group was compared against biopsy (N=309) or clinical follow-up with imaging (N=134) results. The ROMA sensitivity and specificity for predicting epithelial OC (EOC) and borderline ovarian tumor (BOT) were calculated for the suggested and adjusted cutoff values.
RESULTS
When targeting BOT and EOC, the prevalence was 7.4% and sensitivity and specificity at the suggested cutoff were 63.6% and 90.7%, respectively. Sensitivity was 81.8% at the 4.65%/13.71% cutoff set to a specificity of 75.0%. When targeting only EOC, the prevalence was 4.1% and sensitivity and specificity at the suggested cutoff were 77.8% and 89.4%, respectively. Sensitivity was 88.9% at the 4.78%/14.35% cutoff set to a specificity of 75.0%.
CONCLUSIONS
The sensitivity of ROMA was lower than expected when using the suggested cutoff. When using the adjusted cutoff, its sensitivity reached 80.0%.

Keyword

Borderline ovarian tumor; Epithelial ovarian cancer; Risk of Ovarian Malignancy Algorithm; Sensitivity; Specificity; Prevalence

MeSH Terms

Biopsy
Epididymis
Female
Follow-Up Studies
Humans
Korea*
Male
Ovarian Neoplasms
Prevalence
Roma
Sensitivity and Specificity

Figure

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  Fig. 1 Flow chart of patients.Abbreviations: ROMA, risk of ovarian malignancy algorithm; EOC, epithelial ovarian cancer; BOT, borderline ovarian tumor.

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  Fig. 2 Serum concentrations of (A) HE4, (B) CA125, and (C) ROMA for each disease group and menopausal status (N=443). The cutoffs are shown as horizontal lines.Abbreviations: HE4, human epididymis protein 4; CA125, cancer antigen 125; ROMA, risk of ovarian malignancy algorithm; BOT, borderline ovarian tumor; EOC, epithelial ovarian cancer; Non-EOC, non-epithelial ovarian cancer.

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