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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%).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endometrial carcinoma( cases) | 42 patients with abnormal uterine bleeding and diagnosed endometrial cancer at prior endometrial biopsy, underwent staging laparotomy will be subjected to withdrawal of blood sample for measurement of human epididymis protein 4 |
| |
| benign diseases(control) | 42 patients with abnormal uterine bleeding and diagnosed benign endometrial pathology by endometrial biopsy will be subjected to withdrawal of blood sample for measurement of human epididymis protein 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human epididymis protein 4 | Diagnostic Test | Human epididymis protein will be quantitatively assayed using the enzyme immunometric assay (EIA) method |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relation between preoperative level of human epididymis protein 4 and surgicopathological staging of endometrial carcinoma | following staging laparotomy for cases of endometrial carcinoma , the result of pathology will be correlated to HEP4 | one week |
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Inclusion Criteria:
Exclusion Criteria:
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1- History taking, general examination , pelvic ultrasound will be done for all patients under the study,endometrial biopsy will be obtained form all patients and will be reviewed by the pathologists.
6- Computed axial tomography (CT scan) will be done for patient with endometrial carcinoma (case study) for detect tumor as a part of metastatic workup.
7- Pre-operative complete investigation will be done for patient underwent staging lapratomy (CBC, kidney function tests , liver function tests, FBS and coagulation profile to rule out systemic causes of bleeding.
8- Blood sample will be taken from all patients to assess serum level of HE4.
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| Name | Affiliation | Role |
|---|---|---|
| Hayam F Mohammad, MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 25, 2019 | |
| Unrelease | Jan 26, 2019 | |
| Release | Jan 26, 2019 | |
| Unrelease | Jan 27, 2019 | |
| Release | Jan 27, 2019 | |
| Reset | Apr 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 25, 2019 | Jan 26, 2019 | |||
| Jan 26, 2019 | Jan 27, 2019 |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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blood sample for polymerase chain reaction for human epididymis protein 4. endometrial sample in formalin for pathological examination
|
| Jan 27, 2019 | Apr 19, 2019 |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |