Human Epididymis Protein 4 in Endometrial Carcinoma

NCT ID: NCT03456791

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-07-30

Brief Summary

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%).

Detailed Description

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.

Conditions

Endometrial Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Human epididymis protein 4

Intervention Type: DIAGNOSTIC_TEST

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

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

Human epididymis protein 4

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Human epididymis protein 4

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Major epididymis specific protein E4; putative protease inhibitor WAP5

Eligibility Criteria

Inclusion Criteria

• Age (45 - 70 yr old).

Exclusion Criteria

1. Age more than 70 yr and less than 40 yr.

2. Abnormal cardiac hematological renal hepatic functions.

3. Breast cancer or other malignancies.

4. Concomitant benign and for malignant adnexal pathologies.

5. Hormonal medication.

6. Patient taking or having chemo-radiotherapy.

7. Patients unfit for surgical intervention.

8. Smoker.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hayam Fathy Mohammad

Assisted professor of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hayam F Mohammad, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

4

Identifier Type: -

Identifier Source: org_study_id