Evidence map›Paper›PMID 33592901›Full record

Observational studyMedicine2021

A strengthening the reporting of observational studies in epidemiology (STROBE): Are HE4 and CA 125 suitable to detect a Paget disease of the vulva?

Miriam Dellino, Giulio Gargano, Raffele Tinelli, Carmine Carriero, Carla Minoia, Skrypets Tetania, Erica Silvestris, Vera Loizzi, Angelo Paradiso, Porzia Casamassima and 3 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.9field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 24 citations in OpenAlex.

  1. Article
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  12. Roles of Antimicrobial Peptides in Gynecological Cancers.International journal of molecular sciences · 2022
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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

13 authors at 3 institutions in 1 country.

Miriam DellinoGynecologic Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II" Bari.ORCID 0000-0003-3522-4648
Giulio GarganoGynecologic Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II" Bari.
Raffele TinelliDepartment of Obstetrics and Gynecology, "Valle d'Itria" Hospital, Martina Franca, Taranto.
Carmine CarrieroDepartment Interdisciplinary Medicine, Unit of Obstetrics and Gynecology, University of Bari "Aldo Moro".
Carla MinoiaHaematology Unit, IRCCS Istituto Tumori "Giovanni Paolo II" Bari.
Skrypets TetaniaHaematology Unit, National Cancer Center, IRCCS Istituto Tumori "Giovanni Paolo II", viale O. Flacco 65, Bari, Italy; Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia.
Erica SilvestrisGynecologic Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II" Bari.
Vera LoizziDepartment of Biomedical Sciences and Human Oncology, Unit of Obstetrics and Gynaecology.
Angelo ParadisoIRCCS Istituto Tumori "Giovanni Paolo II".
Porzia CasamassimaClinical Patology Laboratory, IRCCS Istituto Tumori "Giovanni Paolo II".
Antonio TufaroIstitutional Biobank, IRCCS Istituto Tumori "Giovanni Paolo II" Bari, Italy.
Gennaro CormioDepartment of Biomedical Sciences and Human Oncology, Unit of Obstetrics and Gynaecology.
Vito Michele GarrisiClinical Patology Laboratory, IRCCS Istituto Tumori "Giovanni Paolo II".
Istituto Tumori Bari · ITUniversity of Bari Aldo Moro · ITUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractPaget disease is a complex disorder that can be identified in the breast (mammary Paget disease) or in other locations (extramammary Paget's disease) such as ano-genital skin (Paget disease of the vulva -PVD). This condition is associated with low mortality, but a late diagnosis and recurrence can negatively impact the prognosis. Therefore, the main objective of this study is to evaluate if the human epididymis protein 4 (HE4) and cancer antigen125 (CA125) can promote recognition of PVD in early stages and during the relapses.we have conducted a prospective, observational and laboratory-based study, that included 50 patients, whose 25 healthy women represented the control group and 25 PVD patients, which have been operated in our Oncology Institute, from May 2017 to September 2019. Both in the control group and in PVD patients, the CA-125 and HE4 were evaluated before surgery and after 6 months. Finally, a comparison of markers serum level, both between before/after surgery and with control group, and a ROC (Receiver Operating Characteristic) curve were performed.Dosing the markers in PVD patients, 3/25 (12%) showed a higher value of CA125 and 11/25 (44%) an increased HE4. In addition, after surgical treatment there were no statistically significant difference between levels of CA-125 (P = .3) and HE4 (P = .19). On the other hand, comparing HE4 in PVD patients with the control group, a statistically significant difference was found (P-value = .0036). Contrary, comparing CA-125 in PVD patients with the control group (P-value= .1969), no statistically significant difference was evidenced. Moreover, ROC (Receiver Operating Characteristic) curve showed low sensitivity and specificity for CA125 with area under curve (AUC) = 0.5608. Instead, the ROC curve of HE4 revealed a sensitivity and specificity of 76% and 88% respectively (AUC = 0.7408) using a cut-off at 90 pmol/L.Despite the limited cases, our data showed that CA125 is not a sensitive marker for PVD. On the other hand, in 44% of PVD we've seen an increase in HE4. So, this could be a starting point for further research that could confirm the possibility to use this marker in order to support PVD early identification.

Indexed as

AgedAged, 80 and overBiomarkersCA-125 AntigenFemaleHumansMiddle AgedPaget Disease, ExtramammaryProspective StudiesROC CurveVulvar DiseasesWAP Four-Disulfide Core Domain Protein 2BiomarkersCA-125 AntigenWAP Four-Disulfide Core Domain Protein 2WFDC2 protein, human

Identifiers

PMID33592901
PMCPMC7870238
OpenAlexW3131884472

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.