Human Epididymis Protein 4 in Endometrial Carcinoma

NCT03456791 | Completed

• 1 other identifier: 4
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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%).

Conditions

Endometrial Cancer

Keywords

Epididymal secretory protein E4; Major epididymis specific protein E4

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Diagnostic Test: 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

Diagnostic Test: Human epididymis protein 4

Interventions

Human epididymis protein 4 DIAGNOSTIC_TEST

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

Also known as: Major epididymis specific protein E4, putative protease inhibitor WAP5

benign diseases(control); endometrial carcinoma( cases)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age (45 - 70 yr old).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for polymerase chain reaction for human epididymis protein 4. endometrial sample in formalin for pathological examination

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hayam F Mohammad, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted professor of obstetrics and gynecology

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: December 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 30, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

EG (1)