HE4

Aliases
  • EDDM4
  • Epididymal secretory protein E4
  • HE4
  • Major epididymis-specific protein E4
  • Putative protease inhibitor WAP5
  • WAP domain containing protein HE4-V4
  • WAP four-disulfide core domain 2
  • WAP four-disulfide core domain 2 [Precursor]
  • WAP5
  • WFDC2
  • dJ461P17.6
  • epididymal protein 4
  • epididymis-specific, whey-acidic protein type, four-disulfide core
Description
11 kDa protein that is a precursor to the epididymal secretory protein HE4; an inhibitor of an as yet unidentified protease. Highly expressed in a number of tumors cells lines, such ovarian, colon, breast, lung and renal cells lines.
OncoMX

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Attributes
QA State
Accepted
Type
Protein
HGNC Name
WFDC2
Certifications
  • None
QA State for Ovary
Accepted
Organ-Specific Notes

Selected for study because of upregulation (mRNA) and overexpression (protein) studies in ovarian cancer.

Performance Comment

Of the 28 ovarian cancer biomarkers tested in prediagnostic specimens, from the PLCO, CA125 remains the the single best biomarker for ovarian cancer and has its strongest signal within six months of diagnosis. HE4 alone was not a strong predictor. In 2009 HE4 was FDA approved to monitor for ovarian cancer recurrence, but not for early detection.

Supporting Study Data
PLCO Ovarian Phase III Validation Study
Study phase on the ovary: 3

Our preliminary data indicate that the performance of CA 125 as a screening test for ovarian cancer can be improved upon by additional biomarkers. With completion of one additional validation step, we will be ready to test the performance of a consensus marker panel in a phase III validation study. Given the original aims of the PLCO trial, we believe that the PLCO represents an ideal longitudinal cohort offering specimens for phase III validation of ovarian cancer biomarkers.

View Protocol
Decision rule: PMID:21372037
SPORE/EDRN/PRE-PLCO Ovarian Phase II Validation Study
Study phase on the ovary: 3

Create a new set of phase II specimens (160 cases with pre-operative bloods representing major histologic types and including 80 early-staged and 80 late-staged cases, 160 controls with benign disease, 480 general population controls, and a small set of serial Samples collected either at least 3 months apart, but not more than 6 months apart OR between 10 months apart and no more than 14 months apart in 40 healthy controls) will be used to evaluate markers identified in preliminary work. The top 5-10 markers, plus an expanded panel of Luminex markers, will comprise a “working consensus panel” for subsequent analysis in PLCO specimens.

View Protocol
Decision rule: PMID:21372037
Validation of Early Detection Ovarian Cancer Biomarkers (Team Project)
Study phase on the ovary: 2

Early detection of Ovarian Cancer (OC) is one of the key clinical problems in this disease. We propose a team EDRN project to address the issue of early detection of OC by performing a validation study on candidate protein markers already identified in previous EDRN research or in the literature (e.g. protein products of TCGA identified mutations specific to ovarian cancer). (See appendix for full listing) Biospecimen sources have been identified which include samples obtained at diagnosis and matched controls (Urban, Godwin, Marks, Skates), and longitudinal samples obtained prior to diagnosis (Urban, Skates, Godwin). Bioinformatic filters will be applied to rank the candidates (Diamandis). In order of ranking, candidate proteins for which high quality antibodies are available will be measured by development of ELISAs at JHU (Chan/Zhang) or through NAPPA at DFCI (Anderson/LaBaer), while for other candidates mass spectrometry based selective reaction monitoring (SRM) assays will be developed at PNNL (Rodland). Three milestones are defined. The first two milestones are to assemble the necessary specimens and to develop the qualifying assay(s). The final milestone is to estimate the markers’ sensitivity one year prior to diagnosis at a given high specificity.

View Protocol
Decision rule: No decision rule specified.
Ovary-Specific Protocols
  • No organ-level protocols specified for ovary.
Ovary-Specific Publications
  • No organ-level publications were listed for ovary.
Ovary-Specific Resources
  • No organ-level resources were given for ovary.