Human Epididymis Protein 4 in Endometrial Carcinoma

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456791
• Other study ID #: 4
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 30, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Diagnostic Test:
• Human epididymis protein 4
Human epididymis protein will be quantitatively assayed using the enzyme immunometric assay (EIA) method

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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