Performance of ROMA based on Architect CA 125 II and HE4 values in Chinese women presenting with a pelvic mass: A multicenter prospective study

Shen, Fengxian; Lü, Shiming; Peng, Yibing; Yang, Fan; Chen, Yan; Lin, Yingying; Yang, Chen; Wu, Li; Li, Huijun; Zheng, Yijie

doi:10.1016/j.cca.2017.05.029

Cited by 11 publications

(10 citation statements)

References 40 publications

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“…Multiple studies, including meta‐analyses, have highlighted the role of HE4 as a potential complement to CA 125, especially in differentiating benign endometriotic and inflammatory lesions in younger women 25,81–103 . Additional tumor markers (as in the ROMA test) have failed to improve significantly the discrimination between benign and malignant masses compared with CA 125 alone 53,81,84,91,96–109 . The combination of a more extended tumor marker profile, including the addition of carcinoembryonic antigen (CEA) and/or carbohydrate antigen (CA 19‐9) to CA 125, is useful mainly for differentiating between metastatic tumors from the gastrointestinal tract or pancreas and primary ovarian malignancy 110–113 .…”

Section: Resultsmentioning

confidence: 99%

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumors

Timmerman

Bourne

Landolfo

et al. 2021

Ultrasound in Obstet & Gyne

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The European Society of Gynaecological Oncology (ESGO), the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG), the International Ovarian Tumour Analysis (IOTA) group and the European Society for Gynaecological Endoscopy (ESGE) jointly developed clinically relevant and evidence-based statements on the preoperative diagnosis of ovarian tumors, including imaging techniques, biomarkers and prediction models.ESGO/ISUOG/IOTA/ESGE nominated a multidisciplinary international group, including expert practising clinicians and researchers who have demonstrated leadership and expertise in the preoperative diagnosis of ovarian tumors and management of patients with ovarian cancer (19 experts across Europe). A patient representative was also included in the group. To ensure that the statements were evidence-based, the current literature was reviewed and critically appraised.Preliminary statements were drafted based on the review of the relevant literature. During a conference call, the whole group discussed each preliminary statement and a first round of voting was carried out. Statements were removed when consensus among group members was not obtained. The voters had the opportunity to provide comments/suggestions with their votes. The statements were then revised accordingly. Another round of voting was carried out according to the same rules to allow the whole group to evaluate the revised version of the statements. The group achieved consensus on 18 statements.This Consensus Statement presents these ESGO/ ISUOG/IOTA/ESGE statements on the preoperative diagnosis of ovarian tumors and the assessment of carcinomatosis, together with a summary of the evidence supporting each statement.

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Section: Resultsmentioning

confidence: 99%

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumors

Timmerman

Bourne

Landolfo

et al. 2021

Ultrasound in Obstet & Gyne

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“…For example, 55 studies selected participants based on disease status, 31 studies included patients below 18 years, and 19 others were excluded because it was not possible to assess eligibility due to incomplete reporting (Table S1). A final set of 17 studies was included in this review, [14][15][16][26][27][28][29][30][31][32][33][34][35][36][37][38][39] of which a total of 13 studies could be included in meta-analyses; seven studies in the main analysis of HE4, 26,30,34,[36][37][38][39] eight studies in the main analysis of CA125, 26,27,[29][30][31][32]34,37 four studies in the comparative analysis, 26,30,34,37 four in the HE4 subgroup analysis 28,29,32,33 and six in the CA125 subgroup analysis 26,28,29,32,33,35 (Figure…”

Section: Search Resultsmentioning

confidence: 99%

The diagnostic accuracy of human epididymis protein 4 (HE4) for discriminating between benign and malignant pelvic masses: a systematic review and meta‐analysis

Olsen

Lof

Stiekema

et al. 2021

Acta Obstet Gynecol Scand

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Introduction: Many women with benign pelvic masses, suspected of ovarian cancer, are unnecessarily referred for treatment at specialized centers. There is an unmet clinical need to improve diagnostic assessment in these patients. Our objective was to obtain summary estimates of the accuracy of human epididymis protein (HE4) for diagnosing ovarian cancer and to compare the performance of HE4 with that of cancer antigen 125 (CA125). Material and methods:We searched PubMed, Ovid and Scopus using search terms for "pelvic masses" and "HE4", to identify studies that evaluated HE4 for diagnosing malignant ovarian masses, in adult women presenting with a pelvic mass, suspected of ovarian cancer, and with diagnosis confirmed by histopathology. Screening, data extraction and Risk of Bias assessment with the QUADAS-2 tool were done independently by two authors. We performed a meta-analysis of the accuracy of HE4 and CA125 using a random-effects bivariate logit-normal model. A study protocol was registered at PROSPERO (CRD42020158073).Results: In the 17 eligible studies, which included 3404 patients, ovarian cancer prevalence ranged from 15% to 71%. Overall, the studies were heterogeneous. All studies seemed to have recruited patients in specialized settings. A meta-analysis of seven HE4 studies resulted in a mean sensitivity of 79.4% (95% confidence interval [CI] 74.1%-83.8%) and a mean specificity of 84.1% (95% CI 79.6%-87.8%), for cut-off values of 67-72 pmol/L. Based on eight studies, the mean sensitivity of CA125 was 81.4% (95% CI 74.6%-86.2%) and the mean specificity was 56.8% (95% CI 47.9%-65.4%), at a cut-off of 35 U/ml. Given a 40% ovarian cancer prevalence, the positive predictive value (PPV) for HE4 would be 76.9% (71.9%-81.2%) vs 55.6% (50.2%-60.9%) for CA125. The negative predictive value (NPV) would be 85.9 (82.8%-88.6%) and 81.9% (76.2%-86.4%), respectively. At a 15% prevalence, the NPV would be 95.8%The search string consisted of a variety of search terms for "pelvic cysts or tumors" and "human epididymis protein 4" (Appendix S1).The search was performed in MEDLINE (PubMed), Embase (Ovid) (95% CI 94.4%-96.7%) for HE4 and 94.4% (95% CI 92.3%-96.0%) for CA125. The PPV would be 46.9% (40.4%-53.4%) and 24.9% (21.1%-29.2%), respectively.Conclusions: HE4 had higher specificity and similar sensitivity compared with CA125.At high prevalence, PPV was also higher for HE4, but at low prevalence, it had a similar NPV to CA125. The field would benefit from studies conducted in general settings.

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“…Interestingly, mucin 16 ( MUC16 ) and WAF four-disulfide core domain protein 2 ( WFDC2 ) displayed high overall expression in the EC cohort and variable expression in the CC cohort. Mucin 16 (also known as CA125) and WAF four-disulfide core domain protein 2 (also known as HE4) are the only clinically-approved serum markers of ovarian cancer and have been shown to perform better for serous OvCa compared to other subtypes ( Leung et al , 2016 ; Shen et al , 2017 ). Here, our data suggests that serum levels of such tumour markers ( Table 1 ) do not entirely capture the biology of the actual tumours and may actually be dependent on tumour release of the markers into circulation rather than tumour production.…”

Section: Resultsmentioning

confidence: 99%

Unraveling endometriosis-associated ovarian carcinomas using integrative proteomics

et al. 2018

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Background: To elucidate potential markers of endometriosis and endometriosis-associated endometrioid and clear cell ovarian carcinomas using mass spectrometry-based proteomics. Methods: A total of 21 fresh, frozen tissues from patients diagnosed with clear cell carcinoma, endometrioid carcinoma, endometriosis and benign endometrium were subjected to an in-depth liquid chromatography-tandem mass spectrometry analysis on the Q-Exactive Plus. Protein identification and quantification were performed using MaxQuant, while downstream analyses were performed using Perseus and various bioinformatics databases. Results: Approximately 9000 proteins were identified in total, representing the first in-depth proteomic investigation of endometriosis and its associated cancers. This proteomic data was shown to be biologically sound, with minimal variation within patient cohorts and recapitulation of known markers. While moderate concordance with genomic data was observed, it was shown that such data are limited in their abilities to represent tumours on the protein level and to distinguish tumours from their benign precursors. Conclusions: The proteomic data suggests that distinct markers may differentiate endometrioid and clear cell carcinoma from endometriosis. These markers may be indicators of pathobiology but will need to be further investigated. Ultimately, this dataset may serve as a basis to unravel the underlying biology of the endometrioid and clear cell cancers with respect to their endometriotic origins.

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Performance of ROMA based on Architect CA 125 II and HE4 values in Chinese women presenting with a pelvic mass: A multicenter prospective study

Cited by 11 publications

References 40 publications

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumors

ESGO/ISUOG/IOTA/ESGE Consensus Statement on preoperative diagnosis of ovarian tumors

The diagnostic accuracy of human epididymis protein 4 (HE4) for discriminating between benign and malignant pelvic masses: a systematic review and meta‐analysis

Unraveling endometriosis-associated ovarian carcinomas using integrative proteomics

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