Evidence map›Paper›PMID 30992143›Full record

Trial reportGynecologic oncology2019

Multiple biomarker algorithms to predict epithelial ovarian cancer in women with a pelvic mass: Can additional makers improve performance?

Richard G Moore, Alexandra Blackman, M Craig Miller, Katina Robison, Paul A DiSilvestro, Elizabeth E Eklund, Robert Strongin, Geralyn Messerlian

Open access · greenAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  12. Review
  13. Review of biomarker systems as an alternative for early diagnosis of ovarian carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Richard G MooreDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester, Rochester, NY 14620, USA; Center for Biomarkers and Emerging Technologies, Women and Infants Hospital/Brown University, RI 02905, USA; Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital/Brown University, RI 02905, USA. Electronic address: Richard_Moore@URMC.Rochester.EDU.
Alexandra BlackmanDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester, Rochester, NY 14620, USA.
M Craig MillerDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester, Rochester, NY 14620, USA.
Katina RobisonProgram in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital/Brown University, RI 02905, USA.
Paul A DiSilvestroProgram in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital/Brown University, RI 02905, USA.
Elizabeth E EklundCenter for Biomarkers and Emerging Technologies, Women and Infants Hospital/Brown University, RI 02905, USA; Department of Pathology, Women and Infants Hospital/Brown University, RI 02905, USA.
Robert StronginDepartment of Chemistry, Portland State University, Portland, OR 97201, USA.
Geralyn MesserlianCenter for Biomarkers and Emerging Technologies, Women and Infants Hospital/Brown University, RI 02905, USA; Department of Pathology, Women and Infants Hospital/Brown University, RI 02905, USA.
Brown University · USUniversity of Rochester · USPortland State University · US

Funding

Development of an Assay for the Early Detection of Ovarian CancerR01CA136491 · NCI · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI MOORE, RICHARD G. · 2009 to 2013
$1.9M
NCI NIH HHS R01 CA136491
6 · The paper itself

Abstract

introductionManagement of a woman with a pelvic mass is complicated by difficulty in discriminating malignant from benign disease. Many serum biomarkers have been examined to determine their sensitivity for detecting malignancy. This study was designed to evaluate if the addition of biomarkers to HE4 and CA125, as used in the Risk of Malignancy Algorithm (ROMA), can improve the detection of EOC.

methodsThis was an IRB approved, prospective clinical trial examining serum obtained from women diagnosed with a pelvic mass who subsequently underwent surgery. Serum biomarker levels for CA125, HE4, YKL-40, transthyretin, ApoA1, Beta-2-microglobulin, transferrin, and LPA were measured. Logistic regression analysis was performed for various marker combinations, ROC curves were generated, and the area under the curves (AUCs) were determined.

resultsA total of 184 patients met inclusion criteria with a median age of 56 years (Range 20-91). Final pathology revealed there were 103 (56.0%) benign tumors, 4 (2.2%) LMP tumors, 61 EOC (33.1%), 2 (1.1%) non-EOC ovarian cancers, 6 (3.3%) gynecologic cancers with metastasis to the ovary and 8 (4.3%) non-gynecologic cancers with metastasis to the ovary. The combination of HE4 and CA125 (i.e. ROMA) achieved an AUC of 91.2% (95% CI: 86.0-96.4) for the detection of EOC vs benign disease. The combination of CA125, HE4, YKL-40, transthyretin, ApoA1, Beta 2 microglobulin, transferrin, LPA and menopausal status achieved the highest AUC of 94.6% (95% CI: 90.1-99.2) but this combination was not significantly better than the HE4 and CA125 combination alone (p = 0.078).

conclusionsThe addition of select further serum biomarkers to HE4 and CA125 does not add to the performance of the dual marker combination for the detection of ovarian cancer.

Indexed as

AdultAgedAged, 80 and overAlgorithmsbeta 2-MicroglobulinBiomarkers, TumorCA-125 AntigenCarcinoma, Ovarian EpithelialChitinase-3-Like Protein 1Cohort StudiesFemaleHumansMembrane ProteinsMiddle AgedNeoplasm StagingPrealbuminbeta 2-MicroglobulinBiomarkers, TumorCA-125 AntigenCHI3L1 protein, humanChitinase-3-Like Protein 1Membrane ProteinsMUC16 protein, humanPrealbuminProteinsTransferrinTTR protein, humanWAP Four-Disulfide Core Domain Protein 2WFDC2 protein, humanBiomarkersHE4Ovarian cancerROMA

Identifiers

PMID30992143
PMCPMC6666425
OpenAlexW2936438899

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.