Clinical trial NCT03558321: Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
Official title: Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Bleeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.

full history, general and local examination were done. Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces.the level of HE4 was measured. All women underwent hystrospopic guided endometrial biopsy. Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

Detailed description: All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.

Full history was taken , the number of episodes of postmenopausal bleeding, and previous investigations and current medications), general examination was performed and local examination was performed for all patients.

Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces by using electronic calipers. If there was fluid in the uterine cavity it was recorded. Suspected polyp was also recorded.

For the level of HE4: 5 ml of venous blood were withdrawn from all patients. The samples were left to clot. The separated sera were stored at -20˚ until all samples were obtained. Frozen samples were allowed to reach room temperature prior to use. Samples were then mixed thoroughly by gently inverting multiple times before analysis. HE4 was quantitatively assayed using the enzyme immunoassay (EIA) method (Fujirebio Diagnostics, Inc. Göteborg, Sweden). The functional sensitivity of the HE4 EIA is ≤ 25pM. The analytical specificity is 100 ± 15%.

All patients were then submitted to hysteroscopy under general anesthesia and endometrial biopsy.

After hysteroscopy and biopsy, 2 patient proved to have cervical malignancy, 2 patients were unfit for open surgery, and another 6 patients did not show up after. These 10 patients were excluded from the study leaving 90 patients eligible for final analysis .

Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

Eligibility criteria: Inclusion Criteria:

* Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm

Exclusion Criteria:

* • History of other Malignancies

  * Patients on chemo and/or radiotherapy
  * Patients on tamoxifen
  * Patients unfit for surgical intervention
  * Patients on HRT or other hormonal treatment

Primary outcomes:
measure: endometrial pathology
timeFrame: 3 days after hystroscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References: