HE4, CA125 and risk of ovarian malignancy algorithm (ROMA) as diagnostic tools for ovarian cancer in patients with a pelvic mass: An Italian multicenter study

2016 ◽  
Vol 141 (2) ◽  
pp. 303-311 ◽  
Author(s):  
Cesare Romagnolo ◽  
Antonette E. Leon ◽  
Aline S.C. Fabricio ◽  
Martina Taborelli ◽  
Jerry Polesel ◽  
...  
Author(s):  
Darlin Forbes ◽  
Irawan Sastradinata ◽  
Patiyus Agustiansyah ◽  
Theodorus Theodorus

Object: To assess the diagnostic value of Risk of Ovarian Malignancy Algorithm (ROMA) in predicting ovarian malignancy. Methods: Diagnostic test was performed at dr. Mohammad Hoesin Hospital Palembang during June 2016 to November 2016. Data were analized with SPSS version 21.0 and Med-calc statistic. Results: A total of 57 subjects were recruited in this study. Subjects were divided into two groups: the premenopausal and postmenopausal group. Analysis with ROC curve was performed, the ROMA optimal cut-off of ROMA was 23.7% and 48.15% in the premenopausal and the post-menopausal group, respectively. With the optimal cut-off, the sensitivity was 79.41% and specivicity was 75%, positive predictive value wa 73.07% and negative predictive value 83.77% with accuracy 76.92% in diagnosing ovarian malignancy. Compared to RMI-3, the sensitivity was 65.5% and specivicity was 85.7% with accuracy 75.44%. Conclusion: ROMA is not a reliable diagnostic tools of ovarian malignancy. Keywords: CA125, HE4, ovarian cancer, risk of ovarian malignancyalgorithm/ ROMA, risk of ovarian malignancy index/RMI


2020 ◽  
Author(s):  
Ayisha Adeeba Ashmore ◽  
C. Gnanachandran ◽  
I. Luqman ◽  
K. Horrocks

Abstract Background:Recent encouragement in early detection of cancer nationally has significantly increased the number of referrals made through the two-week wait suspected cancer pathway. In particular women with abdominal pain and bloating are frequently having their Ca-125 levels investigated for suspected ovarian cancer and this has led to a significant increase in referrals to the ovarian cancer service. We have conducted this study to help improve the efficiency in which these patients are investigated and to improve future pathways within the referral service. Methods:A retrospective observational outcome study. Data were collected from electronic documents of patients’ referrals, assessments, and clinical correspondences.The study was conducted in a tertiary gynaecology cancer centre with primary care direct referrals. The pelvic mass clinic was the clinic setup with consultation, scan and patient support was available. All patients referred by direct primary care for suspected ovarian cancer over two years with Ca-125 result. Data were collected and analysed from the pelvic mass clinic over 48 months, which was available through electronic documentation. Data included information on their consultation, ultrasound scan findings, any further intervention, surgery, and histological outcome of all patient who underwent biopsies or surgery.Results: Two hundred and eighty-six patients were referred from primary care where the NICE guideline, ‘two-week wait for ovarian cancer’, was applied. Two hundred and twenty-three patients were included in this analysis, who had a Ca-125 result reported at the time of their referral. Out of the 223 patients, 126 patients were discharged with or without a repeat Ca-125 after the initial assessment. Seventeen patients were diagnosed with cancer following the referral, but only 12 of them had a primary ovarian malignancy. Conclusion:Majority of the patients with Ca-125 of more than 35U/mL, who were referred through this pathway, did not have cancer. This message can be disseminated by primary care practitioners who may be able to reassure patients prior to their initial consultation with a gynaecologist. This review queries the future value of using Ca-125 as the basis for referrals from primary care referrals for suspected ovarian malignancy. Further studies are required to assess whether a higher Ca-125 cut off may be used as the basis of referrals for postmenopausal women. One-stop focused gynaecology ultrasound clinic (OSFGUC) where clinicians may assess patients with suspected ovarian cancer symptoms and perform ultrasound scans may be better for managing this patient population.


2021 ◽  
Author(s):  
Chen Ming ◽  
Zhong Pengqiang ◽  
Hong Mengzhi ◽  
Tan Jinfeng ◽  
Yu Xuegao ◽  
...  

Abstract To evaluate whether low coverage whole genome sequencing is suitable for the detection of malignant pelvic mass and compare its diagnostic value with traditional tumor markers. We enrolled 63 patients with a pelvic mass suspicious for ovarian malignancy. Each patient underwent low coverage whole genome sequencing (LCWGS) and traditional tumor markers test. The pelvic masses were finally confirmed via pathological examination. The copy number variants (CNVs) of whole genome were detected and the Stouffers Z-scores for each CNV was extracted. The risk of malignancy (RM) of each suspicious sample was calculated based on the CNV counts and Z-scores, which was subsequently compared with ovarian cancer markers CA125 and HE4, and the risk of ovarian malignancy algorithm (ROMA). Receiver Operating Characteristic Curve (ROC) were used to access the diagnostic value of variables. As confirmed by pathological diagnosis, 44 (70%) patients with malignancy and 19 patients with benign mass were identified. Our results showed that CA125 and HE4, the CNV, the mean of Z-scores (Zmean), the max of Z-scores (Zmax), the RM and the ROMA were significantly different between patients with malignant and benign masses. The area under curve ( AUC) of CA125, HE4, CNV, Zmax, and Zmean was 0.775, 0.866, 0.786, 0.685 and 0.725 respectively. ROMA and RM showed similar AUC (0.876 and 0.837), but differed in sensitivity and specificity. After all, we develop a LCWGS based method for the identification of pelvic mass of suspicious ovarian cancer. LCWGS shows accurate result and could be complementary with the existing diagnostic methods.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ming Chen ◽  
Pengqiang Zhong ◽  
Mengzhi Hong ◽  
Jinfeng Tan ◽  
Xuegao Yu ◽  
...  

AbstractTo evaluate whether low coverage whole genome sequencing is suitable for the detection of malignant pelvic mass and compare its diagnostic value with traditional tumor markers. We enrolled 63 patients with a pelvic mass suspicious for ovarian malignancy. Each patient underwent low coverage whole genome sequencing (LCWGS) and traditional tumor markers test. The pelvic masses were finally confirmed via pathological examination. The copy number variants (CNVs) of whole genome were detected and the Stouffers Z-scores for each CNV was extracted. The risk of malignancy (RM) of each suspicious sample was calculated based on the CNV counts and Z-scores, which was subsequently compared with ovarian cancer markers CA125 and HE4, and the risk of ovarian malignancy algorithm (ROMA). Receiver Operating Characteristic Curve (ROC) were used to access the diagnostic value of variables. As confirmed by pathological diagnosis, 44 (70%) patients with malignancy and 19 patients with benign mass were identified. Our results showed that CA125 and HE4, the CNV, the mean of Z-scores (Zmean), the max of Z-scores (Zmax), the RM and the ROMA were significantly different between patients with malignant and benign masses. The area under curve (AUC) of CA125, HE4, CNV, Zmax, and Zmean was 0.775, 0.866, 0.786, 0.685 and 0.725 respectively. ROMA and RM showed similar AUC (0.876 and 0.837), but differed in sensitivity and specificity. In the validation cohort, the AUC of RM was higher than traditional serum markers. In conclusion, we develop a LCWGS based method for the identification of pelvic mass of suspicious ovarian cancer. LCWGS shows accurate result and could be complementary with the existing diagnostic methods.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ayisha A. Ashmore ◽  
Chellappah Gnanachandran ◽  
Iqra Luqman ◽  
Kathryn Horrocks

Abstract Background Women with abdominal pain and bloating frequently have their Ca-125 levels investigated for suspected ovarian cancer and this has led to a significant increase in referrals to the ovarian cancer service. We have conducted this study to help improve the efficiency in which these patients are investigated and to improve future pathways within the referral service. Methods This was a retrospective observational outcome study. Data were collected from electronic documents of patients’ referrals, assessments, and clinical correspondences over 48 months. The study was conducted in a secondary gynaecology cancer centre with direct referrals from primary care. The pelvic mass clinic was set up to include a consultation and an ultrasound scan with support available for patients if required. All patients included were referred directly from primary care for suspected ovarian cancer with Ca-125 result over a period of 2 years. Results 286 were referred from primary care according to the NICE guidelines of ‘2-week wait for ovarian cancer’. Only 223 patients who had a Ca-125 result reported at the time of their referral were included in the analysis. Out of the 223 patients, 126 patients were discharged with or without a repeat Ca-125 after the initial assessment. 18 patients were diagnosed with cancer following the referral, but only 12 of them had a primary ovarian malignancy. The malignancy rate in women under 50 years of age was 22% (4/18) and 78% (14/18) in women aged 50 or above. Conclusion One-stop focused gynaecology ultrasound clinics where clinicians may assess patients and perform ultrasound scans for suspected cancer, may be better for managing this patient population due to improved efficiencies in waiting times, same day diagnosis and a reduction in waiting times to first appointment. Secondly, the majority of the patients with Ca-125 of more than 35 U/mL, who were referred through this pathway, did not have cancer. This review queries the future value of using Ca-125 as the basis for referrals from primary care for suspected ovarian malignancy. Further studies are required to assess whether a higher Ca-125 cut off may be used as the basis of referrals for premenopausal women.


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