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WFDC2

Basics

Aliases:
This biomarker is also known as:
  • WAP four-disulfide core domain 2 [Precursor],
  • EDDM4,
  • WAP domain containing protein HE4-V4,
  • WAP four-disulfide core domain 2,
  • Epididymal secretory protein E4,
  • Major epididymis-specific protein E4,
  • HE4,
  • Putative protease inhibitor WAP5,
  • WAP5,
  • dJ461P17.6,
  • epididymis-specific, whey-acidic protein type, four-disulfide core,
  • epididymal protein 4,

View in BioMuta

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.

Attributes

QA State: Accepted
Type: Protein
Short Name:
HGNC Name: WFDC2

Organs

The following organs have data associated with this biomarker…

Lung

Attributes

Phase: Two
QA State: Under Review

Overview

Performance Comment

Supporting Study Data

The following studies/protocols provide evidence supporting WFDC2 indications for the Lung…

No supporting studies or protocols found.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

No organ-specific publications defined.

Organ-Specific Resources

No organ-specific resources defined.

Ovary

Attributes

Phase: Three
QA State: Accepted

Overview

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

The following studies/protocols provide evidence supporting WFDC2 indications for the Ovary…

PLCO Ovarian Phase III Validation Study

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 more about this study
Biomarker Characteristics Summary
Notes Sensitivity Specificity Prevalence NPV PPV Specific Assay Type
Cases chosen with diagnosis of ovarian cancer (on average) 9 months prior. Controls were matched to cases by age and timing of specimen collection including general population controls (50%), false positive CA125 (25%), and family history of breast cancer (25%). All cases (n=60). 42.0 95.0 N/A N/A N/A
Cases diagnosed <= 6 months after draw (n=25). 68.0 95.0 N/A N/A N/A
Cases diagnosed > 6 months after draw (n=35). 23.0 95.0 N/A N/A N/A
Decision Rule

PMID:21372037

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

SPORE/EDRN/PRE-PLCO Ovarian Phase II Validation Study

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 more about this study
Biomarker Characteristics Summary
Notes Sensitivity Specificity Prevalence NPV PPV Specific Assay Type
For all cases, using all controls. Results from preliminary analysis, 50% of 114 sample set. Daniel Cramer laboratory. 38.0 95.0 N/A N/A N/A
For early stage (more than 12 months prior to diagnosis), using all controls. Results from preliminary analysis, 50% of 114 sample set. Daniel Cramer laboratory. 51.0 95.0 N/A N/A N/A
For late stage (within 12 months of diagnosis), using all controls. Results from preliminary analysis, 50% of 114 sample set. Daniel Cramer laboratory. 17.0 95.0 N/A N/A N/A
Cases chosen with diagnosis of ovarian cancer (on average) 9 months prior. Controls were matched to cases by age and timing of specimen collection including general population controls (50%), false positive CA125 (25%), and family history of breast cancer (25%). All cases (n=60). 42.0 95.0 N/A N/A N/A
Cases diagnosed <= 6 months after draw (n=25). 68.0 95.0 N/A N/A N/A
Cases diagnosed > 6 months after draw (n=35). 23.0 95.0 N/A N/A N/A
Decision Rule

PMID:21372037

Additional Study-Specific Protocols
Study-Specific Publications

No study-specific publications defined.

Study-Specific Resources

No study-specific resources defined.

Organ-Specific Protocols

No organ-specific protocols defined.

Organ-Specific Publications

Organ-Specific Resources

No organ-specific resources defined.

New Funding Opportunity: Biomarker Development Laboratories for the Early Detection Network: Applications Due May 23

Update: Pre-application webinar information now available.

The National Cancer Institute's Division of Cancer Prevention has released a new funding opportunity to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.

The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this funding opportunity) should be focused on one or more of the following cancers: breast, prostate and other genitourinary organs, or lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.

The newly funded units of the Early Detection Research Network will be announced later in April. Successful applicants have already been notified. Those researchers who were not successful during the last round of applications are encouraged to apply to this opportunity.