Postmenopausal BleedingNCT03558321
Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
A study testing Hysteroscopic guided fractional curretage and total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection in people with Postmenopausal Bleeding, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- Hysteroscopic guided fractional curretage and total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postmenopausal Bleeding
- Being tested
- Hysteroscopic guided fractional curretage, total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic guided fractional curretageProcedure or surgery
Under general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue
total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissectionProcedure or surgery
Through abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done
| Study group | Role | What they receive |
|---|---|---|
| post menopausal bleeding | Experimental | women with postmenopausal bleeding and endometrial thickness more than 5 mm Receives: Procedure: Hysteroscopic guided fractional curretage; Procedure: total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial pathology
pathological examination of the endometrial tissue
Measured: 3 days after hystroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startJun 2014
- Primary completionAug 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558321
- Sponsor's protocol ID
- 37
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding
- ClinicalTrials.gov ID
- NCT03558321
- Acronym / sponsor ID
- 37
- Conditions
- Postmenopausal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post menopausal bleeding | Experimental | Procedure: Hysteroscopic guided fractional curretage, Procedure: total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissectionwomen with postmenopausal bleeding and endometrial thickness more than 5 mm |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm
Key exclusion criteria (5 listed)
- • History of other Malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic guided fractional curretageUnder general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue | Procedure or surgery | post menopausal bleeding |
| total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissectionThrough abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done | Procedure or surgery | post menopausal bleeding |
Primary outcome
endometrial pathology
Time frame: 3 days after hystroscopy
pathological examination of the endometrial tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Postmenopausal Bleeding
Recruiting
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Gynaecological Cancers, Ovarian Cancer
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer
Not yet recruitingObservational study
Hysteroscopic Findings With Histopathologic Report of Endometrium in Patients With Postmenopausal Bleeding
Postmenopausal Bleeding
RecruitingObservational study
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
Endometrial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic guided fractional curretage and total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection in people with Postmenopausal Bleeding, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial pathology (time frame: 3 days after hystroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.