Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

Sundar, Sudha; Rick, Caroline; Dowling, Francis; Au, Pui; Snell, Kym I E; Rai, Nirmala; Champaneria, Rita; Stobart, Hilary; Neal, Richard D; Davenport, Clare; Mallett, Susan; Sutton, Andrew; Kehoe, Sean; Timmerman, Dirk; Bourne, Tom; Calster, Ben Van; Gentry‐Maharaj, Aleksandra; Menon, Usha; Deeks, Jonathan J

doi:10.1136/bmjopen-2015-010333

Cited by 21 publications

(17 citation statements)

References 28 publications

(32 reference statements)

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“…The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS) study, a large ongoing prospective study in the UK evaluating a range of diagnostic tests and algorithms for ovarian cancer in secondary care, may provide insight into the most appropriate post-CA125 testing strategy [ 37 ]. Any such strategy should take account of the high incidence of non-ovarian cancers in women with high CA125 levels, as pelvic ultrasound alone will miss many of these malignancies.…”

Section: Discussionmentioning

confidence: 99%

The diagnostic performance of CA125 for the detection of ovarian and non-ovarian cancer in primary care: A population-based cohort study

et al. 2020

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Background The serum biomarker cancer antigen 125 (CA125) is widely used as an investigation for possible ovarian cancer in symptomatic women presenting to primary care. However, its diagnostic performance in this setting is unknown. We evaluated the performance of CA125 in primary care for the detection of ovarian and non-ovarian cancers. Methods and findings We studied women in the United Kingdom Clinical Practice Research Datalink with a CA125 test performed between 1 May 2011–31 December 2014. Ovarian and non-ovarian cancers diagnosed in the year following CA125 testing were identified from the cancer registry. Women were categorized by age: <50 years and ≥50 years. Conventional measures of test diagnostic accuracy, including sensitivity, specificity, and positive predictive value, were calculated for the standard CA125 cut-off (≥35 U/ml). The probability of a woman having cancer at each CA125 level between 1–1,000 U/ml was estimated using logistic regression. Cancer probability was also estimated on the basis of CA125 level and age in years using logistic regression. We identified CA125 levels equating to a 3% estimated cancer probability: the “risk threshold” at which the UK National Institute for Health and Care Excellence advocates urgent specialist cancer investigation. A total of 50,780 women underwent CA125 testing; 456 (0.9%) were diagnosed with ovarian cancer and 1,321 (2.6%) with non-ovarian cancer. Of women with a CA125 level ≥35 U/ml, 3.4% aged <50 years and 15.2% aged ≥50 years had ovarian cancer. Of women with a CA125 level ≥35 U/ml who were aged ≥50 years and who did not have ovarian cancer, 20.4% were diagnosed with a non-ovarian cancer. A CA125 value of 53 U/ml equated to a 3% probability of ovarian cancer overall. This varied by age, with a value of 104 U/ml in 40-year-old women and 32 U/ml in 70-year-old women equating to a 3% probability. The main limitations of our study were that we were unable to determine why CA125 tests were performed and that our findings are based solely on UK primary care data, so caution is need in extrapolating them to other healthcare settings. Conclusions CA125 is a useful test for ovarian cancer detection in primary care, particularly in women ≥50 years old. Clinicians should also consider non-ovarian cancers in women with high CA125 levels, especially if ovarian cancer has been excluded, in order to prevent diagnostic delay. Our results enable clinicians and patients to determine the estimated probability of ovarian cancer and all cancers at any CA125 level and age, which can be used to guide individual decisions on the need for further investigation or referral.

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Section: Discussionmentioning

confidence: 99%

The diagnostic performance of CA125 for the detection of ovarian and non-ovarian cancer in primary care: A population-based cohort study

et al. 2020

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“…The UK ROckETS study 15 may be able to answer several questions regarding the combined use Ca-125, other biomarkers and IOTA principles-based ultrasound scans in characterising the individual risk of…”

Section: Discussionmentioning

confidence: 99%

One-Stop Clinic for Patients with Suspected Ovarian Cancer Pathway from a Retrospective Outcome Study

Ashmore¹,

Gnanachandran²,

Luqman³

et al. 2020

Preprint

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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.

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“…A recent study from Italy by Piovano and colleagues [11] found that adding CA125 and ROMA to triage algorithms for postmenopausal women with adnexal masses improved screening accuracy compared with ultrasound alone; the addition of ROMA was considerably more expensive and provided for minimal additional screening benefit compared with CA125 alone. While economic considerations do play some role in the continued use of CA125 alone for the presurgical assessment of women with adnexal masses, the availability of FDA-cleared multimodal assays and the lack of FDA clearance for the use of CA125 in these clinical situations continue to call into question the ongoing use of a single analyte assay for which there is considerable evidence to support it being an inferior triage process for women presenting with adnexal masses compared with multimodal algorithms [12]. In addition, it begs repeating that the use of any multimodal assay in such cases should not be used for the initial evaluation of an adnexal mass or for the determination of clinical management in such cases.…”

Section: Discussionmentioning

confidence: 99%

Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk

Shulman

Francis²,

Bullock³

et al. 2019

Adv Ther

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IntroductionAdnexal or pelvic mass is a finding that commonly raises suspicion for malignancy, especially for ovarian cancer. Proper identification prior to surgery would permit appropriate referral to a specialty center in cases likely to be ovarian cancer, as optimal outcomes in such cases are obtained when surgical staging and treatment are provided at the time of initial surgery.MethodsWe compared the screening capabilities of two in vitro diagnostic multivariate index assays (IVDMIAs), a new IVDMIA (second-generation multivariate index assay: MIA2G) and a currently used triage algorithm (Risk of Ovarian Malignancy Assay: ROMA).ResultsAmong 245 subjects (24.7%) determined to have a malignancy, ROMA misclassified 51 malignancies (including 10 high-grade ovarian malignancies), whereas MIA2G misclassified 22 (including 5 high-grade ovarian malignancies). Early stage cancers were more frequently misclassified by ROMA (20 vs. 8 cases). The rate of “test-negative” malignancies was significantly higher for ROMA, while the rate of “test-positive” benign cases was significantly higher for MIA2G.ConclusionTriage algorithms play an important role in improving clinical outcomes for women presenting with an adnexal mass regardless of the eventual diagnosis. In this study, MIA2G was shown to correctly predict more cases of ovarian cancer than the ROMA algorithm.FundingAspira Labs/Vermillion Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-01010-8) contains supplementary material, which is available to authorized users.

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Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

Cited by 21 publications

References 28 publications

The diagnostic performance of CA125 for the detection of ovarian and non-ovarian cancer in primary care: A population-based cohort study

The diagnostic performance of CA125 for the detection of ovarian and non-ovarian cancer in primary care: A population-based cohort study

One-Stop Clinic for Patients with Suspected Ovarian Cancer Pathway from a Retrospective Outcome Study

Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk

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