Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
Primary Purpose
Postmenopausal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hysteroscopic guided fractional curretage
total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection
Sponsored by
About this trial
This is an interventional diagnostic trial for Postmenopausal Bleeding
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
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
post menopausal bleeding
Arm Description
women with postmenopausal bleeding and endometrial thickness more than 5 mm
Outcomes
Primary Outcome Measures
endometrial pathology
pathological examination of the endometrial tissue
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03558321
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
post menopausal bleeding
Arm Type
Experimental
Arm Description
women with postmenopausal bleeding and endometrial thickness more than 5 mm
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic guided fractional curretage
Intervention Description
Under general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue
Intervention Type
Procedure
Intervention Name(s)
total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection
Intervention Description
Through abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done
Primary Outcome Measure Information:
Title
endometrial pathology
Description
pathological examination of the endometrial tissue
Time Frame
3 days after hystroscopy
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
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