Human Epididymis Protein 4 in Endometrial Carcinoma

Endometrial cancer represents the most common gynecologic cancer, and it is expected to become an even greater public health concern as the prevalence of obesity, one of the most common risk factors for endometrial cancer, increases worldwide.

Almost 20% of patients with endometrial cancer are in the premenopausal state and 10% are asymptomatic. In such a case, it is much harder to make an early diagnosis and usually they are probably diagnosed at advanced stages.

An earlier diagnosis represents an imperative goal to improve survival and prognosis of patients of endometrial cancer. Actually, there are no certified screening tools for endometrial cancer. Pelvic ultrasound as screening for endometrial cancer-reaches 80.5% of sensitivity, when endometrial echo is > 5 mm, but it dramatically decreases to 20% in asymptomatic women; moreover, specificity is low (61%).

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

45 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams University

Cairo, Egypt

About this study

Human epididymis protein 4, a putative protease inhibition containing two Whey Acid Protein domains, is significantly increased in the endometrioid subtype of endometrial carcinoma.

Tissue microarray and polymerase chain reaction studies confirmed a high level of human epididymis 4 expression in both endometrioid and serous types of endometrial carcinoma , these results are consistent with those from other laboratories showing increased human epididymis protein 4 messenger ribonucleic acid and protein expression in endometrial cancer tissues.

Subsequent investigation demonstrated that human epididymis protein 4 are detectable in various normal tissues with varying expression levels, yet their levels are significantly increased in endometrial carcinoma compared to normal endometrium.

Human epididymis protein 4 ( HE4) is a member of the whey-acidic protein family and it is . Human epididymis protein 4 was first isolated from the human epididymis .

This protein is also known as epididymal secretory protein E4, major epididymis specific protein E4 and putative protease inhibitor WAP5. WFDC-2 gene product was originally thought to be a protein specifically expressed in the epididymis and was dubbed as a tissue marker for the same.

Angioli etal 2013, found HE4 cutoff of 70pmol/l yields the best sensitivity and specificity for detecting endometrial cancer (59.4%) sensitivity and 100% specificity) with a positive predictive value 100% and negative predictive value equal to 71.52% for the 70 pmol/l cutoff, also found that HE4 marker was never increased in patients with benign diseases Kalogera etal 2012 found that HE4 is elevated in high proportion of endometrial cancer patients and it is correlated with myometrial invasion (> 50% P< 0.00) also found that lymph node, statue correlates with the HE4 values there is a statistical significant difference comparing stage I versus stage III (P < 0.0010).

These findings suggest that HE4 could be useful as a preoperative indicator to identify patients suitable for pelvic and para aortic lymphadenectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age (45 - 70 yr old).

Exclusion criteria

Age more than 70 yr and less than 40 yr.
Abnormal cardiac hematological renal hepatic functions.
Breast cancer or other malignancies.
Concomitant benign and for malignant adnexal pathologies.
Hormonal medication.
Patient taking or having chemo-radiotherapy.
Patients unfit for surgical intervention.
Smoker.

Treatment and study plan

Human epididymis protein 4

Diagnostic Test

Human epididymis protein will be quantitatively assayed using the enzyme immunometric assay (EIA) method

Other names: Major epididymis specific protein E4, putative protease inhibitor WAP5

Primary outcomes

Relation between preoperative level of human epididymis protein 4 and surgicopathological staging of endometrial carcinoma

Time frame: one week

following staging laparotomy for cases of endometrial carcinoma , the result of pathology will be correlated to HEP4

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Disease and Endometrial Cancer

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Mar 7, 2018
Registry last updated: Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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