Clinical value of O-RADS combined with serum CA125 and HE4 for the diagnosis of ovarian tumours

Abstract

Background

Ovarian tumors (OTs) are common gynecological tumors in women. It is very important to correctly distinguish benign and malignant OTs.

Purpose

To assess the diagnostic performance of the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) and evaluate the clinical value of O-RADS combined with serum carbohydrate antigen 125 (CA125) and human epididymis protein 4 (HE4) in differentiating benign from malignant OTs.

Material and Methods

A retrospective analysis was performed on 431 cases including pathology and clinical data. The receiver operating characteristic (ROC) curve was drawn, and sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated.

Results

In premenopausal women, O-RADS and O-RADS combined with serum CA125 and HE4 showed sensitivity at 92.2% and 94.8%, specificity at 91.8% and 93.4%, and accuracy at 91.9% and 93.8%, respectively. In postmenopausal women, the sensitivity of O-RADS, O-RADS combined with serum CA125 and HE4 was 94.8% and 95.8%, specificity was 83.9% and 93.6%, and accuracy was 90.5% and 95.6%, respectively. The sensitivity, specificity, and accuracy of O-RADS combined with CA125 and HE4 in premenopausal and postmenopausal women were higher than that of O-RADS (P<0.05).

Conclusion

O-RADS has high diagnostic performance in OTs. When O-RADS is combined with CA125 and HE4 in the diagnosis of OTs, the sensitivity and specificity are improved, which is helpful to improve the diagnostic efficiency of OTs and has high clinical application value.

Keywords

Ovarian tumors O-RADS diagnostic performance ultrasound

Introduction

Ovarian cancer is one of the most common gynecological cancers; it ranks eighth as a cause of death from cancer in women, only after cervical and uterine cancer (1). Ovarian cancer has the characteristics of high rate of recurrence, high rate of metastasis, and low rate of survival. Due to the ovary being located deep in the pelvic cavity, there are no obvious symptoms in the early stage, thus the general survival rate is <50% (2). According to research (3), about 60% of patients are diagnosed with terminal cancer on the first visit, which seriously affects the time of treatment. Therefore, early diagnosis and clinical intervention are the keys to improving the survival rate.

At present, there is no effective method for the screening of ovarian tumors (OTs), and the most urgent task is to find an effective method of diagnosing OTs (4). Ultrasound is the modality of choice for the adequate assessment of OTs; it is a safe, cost-effective, and well-tolerated method of imaging, which can be widely used with high sensitivity and specificity (90%–97%) (5 –7).

It is generally believed that the most accurate method for preoperative diagnosis of OTs is a subjective assessment by experienced sonographers (8). In addition, many diagnostic scoring systems and models for OTs have been developed around the world, aiming to provide help for less experienced sonologists in diagnosing OTs, all of which have been externally validated (9 –14). The American College of Radiology (ACR) published the Ovarian-Adnexal Reporting and Data System (O-RADS), which aims to improve the standardization of describing the ultrasound characteristics of OTs.

Serum tumor markers can provide laboratory evidence for the screening of OTs. Currently, the most used serum biomarkers for the early diagnosis of ovarian cancer are carbohydrate antigen 125 (CA125), but for endometriosis, inflammatory disease of the peritoneum among others is also increased . Therefore, the CA125 has a low specificity in the early stages of OTs (15). Human epididymis protein 4 (HE4) is considered a reliable biomarker for the early diagnosis of OTs according to studies (16,17), with good specificity. Studies (16,18) have shown that the HE4 and CA125 are complementary, which can reduce the rate of misdiagnosis and improve the accuracy of early diagnosis of OTs.

The aim of the present study was to assess the diagnostic performance of O-RADS and evaluate the clinical value of O-RADS combined with serum CA125 and HE4 in differentiating benign from malignant OTs. The evaluation would be done separately for premenopausal and postmenopausal women to eliminate the influence of menstruation on the research, thereby providing a more valuable method for the diagnosis of OTs.

Material and Methods

Participants

This was a retrospective study conducted in a participating research hospital. The study was approved by the ethics committee of the participating institution. From February 2020 to October 2021, patients with OTs who received surgery and obtained pathological results in our hospital were collected. The inclusion criteria were as follows: (i) patients were diagnosed with OT by ultrasound; (ii) patients were detected using CA125 and HE4; and (iii) ovaries had not undergone surgery, radiotherapy, or chemotherapy. The exclusion criteria were as follows: (i) incomplete evaluation and normal ovary (O-RADS 0 and O-RADS 1); (ii) patients without complete clinical data; and (iii) pregnant women.

Methods

Pathology was collected; age and premenopausal/postmenopausal data were recorded for each patient. Postmenopausal women were defined as having no menstruation for 12 months and/or a history of hysterectomy. CA125 and HE4 were collected from all patients before surgery; the levels of CA125 and HE4 were measured by a Cobas e601 full-automatic chemiluminescence immunoassay system (Roche Diagnostics). CA125 and HE4 levels exceeding the cutoff levels were positive, and CA125 and HE4 levels lower than or equal to the cutoff levels were negative. The joint examinations had a positive result if one or more detection results were positive. If all detection results were negative, the joint examinations could be considered negative.

The GE Voluson E8, GE Voluson E10 (Made in China by General Electric Company) and Mindray Reasona 8 T (Made by Mindray in China) were used for transabdominal or transvaginal ultrasound examination, respectively. All ultrasound examinations were conducted by sonologists with experience without knowing the pathological results. The focus was on the following morphological characteristics for each examined OT: laterality (unilateral or bilateral); lesion category; maximum diameters; wall thickness; external contour; solid areas; number and size solid papillary projections; the presence of ascites or peritoneal implant; and the pattern and score of color Doppler. Borderline tumors were defined as malignant in the present study. If a patient has ≥2 OTs, the largest one or the one with complex ultrasonographic features were included.

The details of O-RADS are shown in Table 1. According to previous literature (19,20), the diagnostic performance is better when O-RADS 4 to 5 is considered malignant. Therefore, O-RADS 1 to 3 were defined as benign masses and O-RADS 4 to 5 as malignant masses in this study.

Table 1.

O-RADS risk stratification.

O-RADS	Risk category	Lexicon descriptors
0		Incomplete evaluation
1	Normal ovary	Follicle ≤3 cm, corpus ≤3cm
2	Almost certainly benign (<1%)	Simple cyst <10 cm Classic benign lesions: hemorrhagic (<10 cm), mature teratoma (<10 cm) endometrioma (<10 cm), para-ovarian cyst (any size), peritoneal inclusion cyst (any size), hydrosalpinx (any size) Non-simple unilocular (smooth inner margin) <10 cm
3	Low-risk malignancy (1%–10%)	Unilocular cyst ≥10 cm (simple or non-simple) Typical dermoid cysts, endometriomas, hemorrhagic cysts ≥10 cm Unilocular cyst, any size, irregular inner wall (thickness <3 mm) Multilocular cyst <10 cm, smooth inner wall, CS = 1–3 Solid smooth, any size, CS = 1
4	Intermediate risk (10%–50%)	Multilocular cyst with no solid component (≥10 cm, smooth inner wall, CS = 1–3; any size, smooth inner wall, CS = 4; any size, irregular inner wall and/or irregular septation, any color score) Unilocular cyst with solid component, any size, 0–3 papillary projections (height >3 mm), any color score Multilocular cyst with solid component, any size, CS = 1–2 Solid, any size, smooth inner wall, CS = 2–3
5	Hight risk (>50%)	Unilocular cyst, any size, ≥4 papillary projections, any color score Multilocular cyst with solid component, any size, CS = 3–4 Solid smooth, any size, CS = 4 Solid irregular, any size, any color score Ascites and/or peritoneal nodules

CS, color score; O-RADS, Ovarian-adnexal Reporting and Data System.

Statistical analysis

SPSS version 26.0 (IBM, Armonk, NY, USA) or MedCalc version 19.0 (MedCalc, Ostend, Belgium) were used for the statistical analyses. Categorical variables were presented as numbers and percentages and compared using the chi-square test. Continuous variables conforming to the normal distribution were presented as mean ± standard deviation and compared by independent sample t-test. Continuous variables conforming to the non-normal distribution were presented as medians and quartiles, compared by U-test. Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and Youden index were calculated. The receiver operating characteristic (ROC) curve was applied to determine the best cutoff, calculate the area under the curve (AUC), and comparatively analyze the validity. Ultrasound morphological characteristics were analyzed by univariate and multivariate analysis; logistic regression was applied in the multivariate analysis. P < 0 0.005 was considered statistically significant.

Results

General clinical characteristics

A total of 431 patients (273 premenopausal patients, 158 postmenopausal patients; age range = 15–87 years) were enrolled in the study. There were 258 benign tumors and173 malignant tumors. Of the 431 masses, 79 were classified as O-RADS 2, 168 as O-RADS 3, 86 as O-RADS 4, and 98 as O-RADS 5. The pathology and O-RADS classification are summarized in Table 2. Table 3 shows the general clinical characteristics of these patients. The age and levels of serum CA125 and HE4 of the group with malignant OTs were higher than those of the group with benign tumors (P<0.001). Malignant tumors were more frequent in postmenopausal women (P<0.001). However, there is no difference in the incidence of unilateral or bilateral between benign and malignant tumors (P = 0.328). The general clinical characteristics of premenopausal women and postmenopausal women were shown in Table 4.

Table 2.

O-RADS classification and pathology among tumors included in the study.

Pathology	O-RADS				Total	%
Pathology	2	3	4	5	Total	%
Serous cystadenoma	9	34	2	0	45	10.4
Mucinous cystadenoma	9	44	0	0	53	12.3
Para-ovarian cyst	5	1	0	0	6	1.4
Endometrioma	20	19	4	3	46	10.7
Simple cyst	8	5	0	0	13	3.0
Mature teratoma	23	38	0	0	61	14.2
Fibroma	1	12	2	1	16	3.7
Hemorrhagic cyst	1	0	5	0	6	1.4
Theca cell tumors	0	5	2	1	8	1.9
Ovarian goiter	0	2	1	0	3	0.7
Brenner tumor	2	0	0	0	2	0.5
Borderline serous cystadenoma	0	1	13	3	17	3.9
Borderline mucinous cystadenoma	1	3	8	1	13	3.0
Borderline clear cell carcinoma	0	0	1	0	1	0.2
Serous carcinoma	0	2	17	72	91	21.1
Mucinous carcinoma	0	0	6	2	8	1.9
Clear cell carcinoma	0	1	10	5	16	3.7
Immature teratoma	0	0	1	1	2	0.5
Endometrioid carcinoma	0	0	5	1	6	1.4
Metastatic tumor	0	0	2	2	4	0.9
Granular cell tumor	0	1	5	0	6	1.4
Yolk sac tumor	0	0	0	2	2	0.5
Undifferentiated carcinoma	0	0	1	0	1	0.2
Carcinosarcoma	0	0	0	1	1	0.2
Small neuroendocrine carcinoma	0	0	1	0	1	0.2
Squamous cell carcinoma	0	0	0	1	1	0.2
Dysgerminoma	0	0	0	2	2	0.5
Total	79	168	86	98	431	100.0

O-RADS, Ovarian-adnexal Reporting and Data System.

Table 3.

General clinical characteristics of the 431 patients.

		Pathologic results
		Malignant (n = 173)	Benign (n = 258)	P
Age (years)		52.09 ± 13.16	40.21 ± 16.01	<0.001
Postmenopausal	Yes	96	62	<0.001
Postmenopausal	No	77	196	<0.001
Unilateral or bilateral	Unilateral	58	75	0.326
Unilateral or bilateral	Bilateral	75	183	0.326
CA125 (U/mL)		186.40 (36.19–605.85)	19.41 (12.24–34.97)	<0.001
HE4 (pmol/L)		131.40 (56.75–405.30)	43.2 (37.15–52.32)	<0.001

Values are given as n, mean ± SD, or median (range).

CA125, carbohydrate antigen 125; HE4, human epididymis protein 4.

Table 4.

General clinical characteristics in premenopausal and postmenopausal women of 431 patients.

		Pathologic results
		Malignant (n = 173)	Benign (n = 258)	P
Premenopausal
Age (years)		41.48 ± 11.28	33．21 ± 10.12	<0.001
Unilateral or bilateral	Unilateral	12	12	0.095
Unilateral or bilateral	Bilateral	65	179	0.095
CA125 (U/mL)		73.10 (33.10–388.10)	20.69 (13.17–37.73)	<0.001
HE4 (pmol/L)		71.70 (46.90–277.20)	41.30 (36.29–48.50)	<0.001
Postmenopausal
Age (years)		60.59 ± 6.90	62.34 ± 9.93	0.195
Unilateral or bilateral	Unilateral	23	1	<0.001
Unilateral or bilateral	bilateral	73	61	<0.001
CA125 (U/mL)		398.90 (49.72–800.50)	16.24 (12.02–23.18)	<0.001
HE4 (pmol/L)		170.40 (82.13–494.0)	57.80 (43.90–69.12)	<0.001

Values are given as n, mean ± SD, or median (range).

CA125, carbohydrate antigen 125; HE4, human epididymis protein 4.

Univariate and multivariate analysis of ultrasound characteristics

Table 5 shows the univariate and multivariate analysis of ultrasonographic characteristics related to OTs. Lesion category, maximum diameters, irregular external contour, color score, and ascites were all related to malignant tumors in the univariate and multivariate analyses (P<0.001).

Table 5.

Univariate and multivariate analyses of ultrasound characteristics in OT.

Ultrasound characteristics		Pathologic results		Univariate analysis	Multivariate analyses
		Malignant (n = 173)	Benign (n = 258)	P	P	OR (95% CI)
Lesion category	Unilocular with no solid component	5	192	<0.001
	Unilocular with solid component	92	4		<0.001	0.005 (0.01–0.30)
	Multilocular cyst with no solid component	7	38		0.33	0.152 (0.03–0.86)
	Multilocular cyst with solid component	17	2		<0.001	0.06 (0.01–0.70)
	Solid	52	22		<0.001	0.039 (0.08–0.19)
Maximum diameters (cm)	D ≤ 3*	2	10	<0.001
	3 < D ≤ 5	12	54		0.965	0.916 (0.02–46.62)
	5 < D < 10	65	105		0.908	1.246 (0.03–51.61)
	D ≥ 10	94	89		0.394	0.199 (0.05–8.15)
Papillary projections	0–3	134	244	<0.001	0.099	2.333 (0.85–6.37)
Papillary projections	≥4	39	14	<0.001	0.099	2.333 (0.85–6.37)
Irregular external contour	Yes	146	17	<0.001	<0.001	32.78 (16.47–65.24)
Irregular external contour	No	27	241	<0.001	<0.001	32.78 (16.47–65.24)
Color score	1*	11	213	<0.001
	2	1	33		0.90	8.333 (0.72–96.81)
	3	40	7		<0.001	0.60 (0.01–0.26)
	4	121	5		<0.001	0.10 (0.003–0.039)
Ascites	Yes	104	7	<0.001	<0.001	13.936 (5.36–36.43)
Ascites	No	69	251	<0.001	<0.001	13.936 (5.36–36.43)

* Control group, OR odds ratio;.

CA125, carbohydrate antigen 125; CI, confidence interval; HE4, human epididymis protein 4; OR, odds ratio; OT, ovarian tumor.

Diagnostic performance of Ca125, He4, O-RADS, and O-RADS combined with Ca125 and He4

The CA125 and HE4 values corresponding to the maximum Youden index of CA125 and HE4 were selected as the optimal critical values for the diagnosis of OT. The critical values of CA125 and HE4 in premenopausal women were 35.1 U/mL and 72.8 pmol/L, respectively, and the critical values of CA125 and HE4 in postmenopausal women were 36.3 U/mL and 145.7 pmol/L. The ROC of CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 in premenopausal and postmenopausal women are shown in Figs. 1 and 2. Table 6 shows the AUC of CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 in premenopausal and postmenopausal women. The AUC of O-RADS combined with CA125 and HE4 was greater than that of CA125, HE4, O-RADS, and O-RADS in premenopausal and postmenopausal women (P<0.05).

Fig. 1.

The ROC of CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 in premenopausal women. CA125, carbohydrate antigen 125; HE4, human epididymis protein 4; O-RADS, Ovarian-adnexal Reporting and Data System; ROC, receiver operating characteristic.

Fig. 2.

The ROC of CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 in postmenopausal women. CA125, carbohydrate antigen 125; HE4, human epididymis protein 4; O-RADS, Ovarian-adnexal Reporting and Data System; ROC, receiver operating characteristic.

Table 6.

The Youden Index and AUC of premenopausal and postmenopausal women.

	Youden Index	AUC	95% CI
Premenopausal
CA125	0.478	0.784	(0.722–0.847)
HE4	0.541	0.808	(0.744–0.872)
O-RADS	0.840	0.945	(0.911–0.978)
O-RADS + CA125 + HE4	0.882	0.964	(0.937–0.991)
Postmenopausal
CA125	0.665	0.881	(0.826–0.935)
HE4	0.695	0.862	(0.805–0.920)
O-RADS	0.787	0.919	(0.870–0.968)
O-RADS + CA125 + HE4	0.894	0.945	(0.906–0.983)

AUC, area under the curve; CA125, carbohydrate antigen 125; CI, confidence interval; HE4, human epididymis protein 4; O-RADS, Ovarian-adnexal Reporting and Data System.

The CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 diagnostic performance values in premenopausal and postmenopausal women are presented in Tables 7 and 8. In premenopausal women, O-RADS and O-RADS combined with serum CA125 and HE4 showed a sensitivity of 92.2% and 94.8%, specificity of 91.8% and 93.4%, and accuracy of 91.9% and 93.8%, respectively. In postmenopausal women, the sensitivity of O-RADS and O-RADS combined with serum CA125 and HE4 was 94.8% and 95.8%, specificity was 83.9% and 93.6%, and accuracy was 90.5% and 95.6%, respectively. The sensitivity, specificity, and accuracy of O-RADS combined with CA125 and HE4 in premenopausal and postmenopausal women were higher than that of O-RADS (P<0.05).

Table 7.

The diagnostic performance of CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 in premenopausal.

	SE	SP	PPV	NPV	AC
CA125	77.9	69.9	50.4	88.9	72.2
HE4	62.3	91.8	75	86.1	83.5
O-RADS	92.2	91.8	81.6	96.7	91.9
O-RADS + CA125 + HE4	94.8*	93.4^†	84.8	97.8	93.8
Chi-square	34.112	64.653	37.611	27.295	63.680
P	<0.001	<0.001	<0.001	<0.001	<0.001

*P<0.05 vs. the separated CA125, HE4, and O-RADS.

^†

P<0.05 vs. the separated CA125 and HE4.

AC, accuracy; CA125, carbohydrate antigen 125; HE4, human epididymis protein 4; O-RADS, Ovarian-adnexal Reporting and Data System; NPV, negative predictive value; PPV, positive predictive value; SE, sensitivity; SP, specificity.

Table 8.

The diagnostic performance of CA125, HE4, O-RADS, and O-RADS combined with CA125 and HE4 in postmenopausal women.

	SE	SP	PPV	NPV	AC
CA125	87.5	79	86.6	80.3	84.2
HE4	76	93.5	94.8	71.6	82.9
O-RADS	94.8	83.9	90.1	91.2	90.5
O-RADS + CA125 + HE4	95.8*	93.6^†	96.8	93.6	95.6
Chi-square	33.265	10.466	8.085	15.707	22.720
P	<0.001	0.015	0.044	0.001	<0.001

*P<0.05 vs. the separated CA125, HE4, and O-RADS.

^†

P<0.05 vs. the separated CA125 and HE4.

Discussion

Ovarian cancer is the main cause of death of female gynecological tumors. Correct diagnosis before surgery is very important to make an appropriate treatment plan and improve the survival rate (21,22). The diagnostic model based on an ultrasound can be used to diagnose benign and malignant OTs. ACR O-RADS uses standardized terms to describe the imaging features of OTs, which reduces or eliminates the inconsistency in the description of the imaging features of OTs by sonologists, resulting in a higher probability of diagnosis (23,24). In this study, we assessed the diagnostic performance of O-RADS and evaluate the clinical value of O-RADS combined with serum CA125 and HE4 in differentiating benign from malignant OTs.

In this study, the AUC of O-RADS in premenopausal and postmenopausal women was 0.945 and 0.919, respectively, which was like that of Lai et al. (11), but lower than that of Basha et al. (19). The reason may be the inclusion of different sample content and pathological types. In the study by Basha et al. (19), borderline tumors accounted for 4.9% of adnexal masses and malignant tumors accounted for 22.6% of adnexal masses, while in this study, borderline tumors accounted for 6.9% of OTs and malignant tumors accounted for 40.1% of OTs. Research (25) has shown that the incidence of malignant tumors is the diagnostic performance of ultrasound for OTs. According to previous literature (11,19,20,24), considering combined O-RADS 4 and O-RADS 5 as a predictor for malignancy, excellent diagnostic performance was obtained. Cao et al. (20) found that the sensitivity and specificity of O-RADS in the diagnosis of benign and malignant OTs were 98.7% and 83.2%, respectively. In this study, the sensitivity of O-RADS in premenopausal and postmenopausal women was 92.2% and 94.8%, and the specificity was 91.8% and 83.9%, respectively. The results are similar to previous studies (20). O-RADS provides a comprehensive description and explanation of the ultrasound morphological features of OT and follow-up management guidelines for determining which OT needs follow-up, further examination, or surgical treatment. To diagnose malignant OTs more objectively and normatively, standardized ultrasound terms are used for some typical lesions, such as simple cyst, hemorrhagic cyst, dermoid cyst, endometrioma, etc. We believe that the above factors may contribute to the high sensitivity of O-RADS. In the study, premenopausal women and postmenopausal women have a different specificity in the O-RADS. This may be due to the fact that in this study, malignant tumors accounted for 28.2% of OTs in premenopausal women and accounted for 60.8% of OTs in postmenopausal women.

The present study analyzed the basic ultrasound characteristics related to OTs. The result shows that lesion category, maximum diameters, irregular external contour, color score, and ascites are all related to the malignancy of the OTs (P < 0.05), while solid papillary projections have nothing to do with malignancy of the OTs (P = 0.099). This shows that standardized ultrasound terminology in O-RADS plays an important role in diagnosing benign and malignant OT. We find that solid papillary projections are mainly seen in serous cystadenoma. Because blood flow signals can be seen in the papillary projections, it is easy to misdiagnose them as a malignant tumor. False-positive cases are mainly seen in O-RADS 4, including four endometriomas, five hemorrhagic, two fibromas, and two theca cell tumors, which are considered to have a high risk of malignancy owing to ultrasonographic characteristics similar to malignant tumors. The specificity of O-RADS is lower than other diagnostic models (12,26 –28). The increase of false-positive cases may lead to a decrease in the specificity of O-RADS, which is the limitation of O-RADS.

Serum tumor markers are an objective method for diagnosing OTs. Although CA125 has certain limitations, it is still the most used classical marker in the clinical diagnosis of OTs (29). HE4 levels have high specificity, which is not affected by the menstrual cycle, hormonal treatment, or endometriosis, and can be used as an additional assessment to ultrasonography (30). In the present study, the critical values of CA125 and HE4 in premenopausal women were 35.1 U/mL and 72.8 pmol/L, respectively, and the critical values of CA125 and HE4 in postmenopausal women were 36.3 U/mL and 145.7 pmol/L, respectively, which are similar to previous studies (31 –33). The study by Lycke et al. (27) reported that the sensitivity of CA125 and HE4 in premenopausal women was 96% and 83%, and the specificity was 60% and 91%, respectively. In postmenopausal women, the sensitivity of CA125 and HE4 was 92% and 72%, and the specificity was 80% and 93%, respectively. Except for the specificity of HE4 in postmenopausal women, our study results are lower than the studies mentioned above (27). The reason may be related to the clinical heterogeneity of the participants and the different proportions of malignant OTs in premenopausal and postmenopausal women.

In order to improve the specificity of O-RADS and reduce the false positives, we combined O-RADS with serum CA125 and HE4 to diagnose benign and malignant OTs. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in premenopausal women was 94.8%, 93.4%, 84.8%, 97.8%, and 93.8%, respectively. In the postmenopausal women, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in premenopausal women was 95.8%, 93.6%, 96.8%, 93.6%, and 95.6%, respectively. The sensitivity and specificity of combined diagnosis were significantly higher than that of O-RADS alone (P < 0.05). These results indicate that O-RADS combined with CA125 and HE4 can provide more valuable diagnostic methods.

The present study has some limitations. First, due to only patients who chose surgical treatment being included in this study, we may have ignored the physiological masses that disappear spontaneously during conservative treatment, which may have led to selection bias. Furthermore, this study is a retrospective study, and all analysis was based on the static images, which may have a certain impact on the accuracy of diagnosis.

In conclusion, lesion category, maximum diameters, irregular external contour, color score, and ascites are all related to malignant tumors, which helps diagnose OT. O-RADS provides standardized ultrasound terms and has high sensitivity in OT. When O-RADS is combined with CA125 and HE4 in the diagnosis of OT, the sensitivity and specificity are improved, which may be a helpful technique for the early detection of OT and has high clinical application value.

Footnotes

Acknowledgements

We would like to thank all participants for their support in this study.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support with respect to the research, authorship, and/or publication of this article.

ORCID iD

Zongli Yang

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