Endometrial Cancer and Endometrial HyperplasiaNCT05619159
the Value of Immunohistochemical Expression of Moesin in Endometrial Hyperplasia and Endometrial Carcinoma
An observational study of Endometrial Cancer and Endometrial Hyperplasia, run by Sohag University at 1 site in Egypt.
Trial summary
Endometrial carcinoma (EC) is the most prevalent invasive carcinoma of the female genital tract in developed countries, while it ranks as the second most frequently occurring neoplasm of women in developing countries, after carcinoma of the cervix uteri. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer and Endometrial Hyperplasia
- What is being tested?
- microscopic pathological evaluation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2022to May 2023
- Phase
- Observational
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: females presented to gynecology department in sohag university hospital and sohag oncology center
Who may be able to join
- Hysterectomy specimens diagnosed as endometrial hyperplasia and endometrial adenocarcinoma.
- All cases of endometrial biopsies obtained by curettage (D\&C) diagnosed as endometrial hyperplasia.
- Cases of cyclical endometrium obtained from endometrial curettage or hysterectomy specimens done for pathological conditions other than hyperplastic or neoplastic endometrial lesions.
- Complete clinical data.
Who cannot join
- Patients with a history of preoperative chemotherapy and /or radiotherapy.
- Biopsies with predominantly blood clots.
- Insufficient or tiny tissue biopsies.
Trial locations and contacts
1 site in 1 country.
afaf t el nashar, professor contact
About this study
Endometrial carcinoma (EC) is the most prevalent invasive carcinoma of the female genital tract in developed countries, while it ranks as the second most frequently occurring neoplasm of women in developing countries, after carcinoma of the cervix uteri. The vast majority of ECs occur in perimenopausal and postmenopausal women .
ECs are classified into two distinct phenotypes; type I which represents more than 80% of all cases of ECs, it has a favorable prognosis. This type is linked to excess, unopposed hyper-estrogenic condition and it is almost always preceded by endometrial hyperplasia. On the contrary, type II endometrial carcinoma is less common than type I, representing less than 10% of all cases of ECs. Type II endometrial carcinomas are high grade, poorly differentiated and estrogen-independent tumors .
- Being tested
- microscopic pathological evaluation
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microscopic pathological evaluationDevice
description of moesin expression between endometrial hyperplasia and endometrial carcinoma
| Study group | Role | What they receive |
|---|---|---|
| endometrial carcinoma smples | Not described Receives: Device: microscopic pathological evaluation | |
| endometrial hyperplasia samples | Not described Receives: Device: microscopic pathological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of immunohistochemical expression of moesin in endometrial hyperplasia and endometrial carcinoma
To evaluate immunohistochemical expression of moesin in normal, hyperplasic and neoplastic endometrial tissues , correlate this expression with different clinicopathologic parameters of endometrial carcinoma and to evaluate the role of moesin as prognostic marker in progression from preinvasive lesions of the endometrium to endometrial carcinoma.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endometrial Cancer and Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Abbas, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619159
- Sponsor's protocol ID
- Soh-Med-22-10-04
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Frose J, Chen MB, Hebron KE, Reinhardt F, Hajal C, Zijlstra A, Kamm RD, Weinberg RA. Epithelial-Mesenchymal Transition Induces Podocalyxin to Promote Extravasation via Ezrin Signaling. Cell Rep. 2018 Jul 24;24(4):962-972. doi: 10.1016/j.celrep.2018.06.092.
PubMed 30044991Wang H, Xiao X, Li Z, Luo S, Hu L, Yi H, Xiang R, Zhu Y, Wang Y, Zhu L, Xiao L, Dai C, Aziz A, Yuan L, Cui Y, Li R, Gong F, Liu X, Liang L, Peng H, Zhou H, Liu J. Polyphyllin VII, a novel moesin inhibitor, suppresses cell growth and overcomes bortezomib resistance in multiple myeloma. Cancer Lett. 2022 Jul 1;537:215647. doi: 10.1016/j.canlet.2022.215647. Epub 2022 Mar 17.
PubMed 35306105Mandelbaum RS, Ciccone MA, Nusbaum DJ, Khoshchehreh M, Purswani H, Morocco EB, Smith MB, Matsuzaki S, Dancz CE, Ozel B, Roman LD, Paulson RJ, Matsuo K. Progestin therapy for obese women with complex atypical hyperplasia: levonorgestrel-releasing intrauterine device vs systemic therapy. Am J Obstet Gynecol. 2020 Jul;223(1):103.e1-103.e13. doi: 10.1016/j.ajog.2019.12.273. Epub 2020 Jan 21.
PubMed 31978437Yuan O, Ugale A, de Marchi T, Anthonydhason V, Konturek-Ciesla A, Wan H, Eldeeb M, Drabe C, Jassinskaja M, Hansson J, Hidalgo I, Velasco-Hernandez T, Cammenga J, Magee JA, Nimeus E, Bryder D. A somatic mutation in moesin drives progression into acute myeloid leukemia. Sci Adv. 2022 Apr 22;8(16):eabm9987. doi: 10.1126/sciadv.abm9987. Epub 2022 Apr 20.
PubMed 35442741
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Value of Immunohistochemical Expression of Moesin in Endometrial Hyperplasia and Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT05619159
- Acronym / sponsor ID
- Soh-Med-22-10-04
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 16 Nov 2022 (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.
Endometrial carcinoma (EC) is the most prevalent invasive carcinoma of the female genital tract in developed countries, while it ranks as the second most frequently occurring neoplasm of women in developing countries, after carcinoma of the cervix uteri. The vast majority of ECs occur in perimenopausal and postmenopausal women .
ECs are classified into two distinct phenotypes; type I which represents more than 80% of all cases of ECs, it has a favorable prognosis. This type is linked to excess, unopposed hyper-estrogenic condition and it is almost always preceded by endometrial hyperplasia. On the contrary, type II endometrial carcinoma is less common than type I, representing less than 10% of all cases of ECs. Type II endometrial carcinomas are high grade, poorly differentiated and estrogen-independent tumors .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial carcinoma smples | – | Device: microscopic pathological evaluation |
| endometrial hyperplasia samples | – | Device: microscopic pathological evaluation |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- females presented to gynecology department in sohag university hospital and sohag oncology center
Key inclusion criteria (4 listed)
- Hysterectomy specimens diagnosed as endometrial hyperplasia and endometrial adenocarcinoma.
- All cases of endometrial biopsies obtained by curettage (D\&C) diagnosed as endometrial hyperplasia.
- Cases of cyclical endometrium obtained from endometrial curettage or hysterectomy specimens done for pathological conditions other than hyperplastic or neoplastic endometrial lesions.
- Complete clinical data.
Key exclusion criteria (3 listed)
- Patients with a history of preoperative chemotherapy and /or radiotherapy.
- Biopsies with predominantly blood clots.
- Insufficient or tiny tissue biopsies.
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 |
|---|---|---|
| microscopic pathological evaluationdescription of moesin expression between endometrial hyperplasia and endometrial carcinoma | Device | endometrial carcinoma smples, endometrial hyperplasia samples |
Primary outcome
The value of immunohistochemical expression of moesin in endometrial hyperplasia and endometrial carcinoma
Time frame: 1 year
To evaluate immunohistochemical expression of moesin in normal, hyperplasic and neoplastic endometrial tissues , correlate this expression with different clinicopathologic parameters of endometrial carcinoma and to evaluate the role of moesin as prognostic marker in progression from preinvasive lesions of the endometrium to endometrial carcinoma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 30044991Frose J, Chen MB, Hebron KE, Reinhardt F, Hajal C, Zijlstra A, Kamm RD, Weinberg RA. Epithelial-Mesenchymal Transition Induces Podocalyxin to Promote Extravasation via Ezrin Signaling. Cell Rep. 2018 Jul 24;24(4):962-972. doi: 10.1016/j.celrep.2018.06.092.
- Background: PubMed 35306105Wang H, Xiao X, Li Z, Luo S, Hu L, Yi H, Xiang R, Zhu Y, Wang Y, Zhu L, Xiao L, Dai C, Aziz A, Yuan L, Cui Y, Li R, Gong F, Liu X, Liang L, Peng H, Zhou H, Liu J. Polyphyllin VII, a novel moesin inhibitor, suppresses cell growth and overcomes bortezomib resistance in multiple myeloma. Cancer Lett. 2022 Jul 1;537:215647. doi: 10.1016/j.canlet.2022.215647. Epub 2022 Mar 17.
- Background: PubMed 31978437Mandelbaum RS, Ciccone MA, Nusbaum DJ, Khoshchehreh M, Purswani H, Morocco EB, Smith MB, Matsuzaki S, Dancz CE, Ozel B, Roman LD, Paulson RJ, Matsuo K. Progestin therapy for obese women with complex atypical hyperplasia: levonorgestrel-releasing intrauterine device vs systemic therapy. Am J Obstet Gynecol. 2020 Jul;223(1):103.e1-103.e13. doi: 10.1016/j.ajog.2019.12.273. Epub 2020 Jan 21.
- Background: PubMed 35442741Yuan O, Ugale A, de Marchi T, Anthonydhason V, Konturek-Ciesla A, Wan H, Eldeeb M, Drabe C, Jassinskaja M, Hansson J, Hidalgo I, Velasco-Hernandez T, Cammenga J, Magee JA, Nimeus E, Bryder D. A somatic mutation in moesin drives progression into acute myeloid leukemia. Sci Adv. 2022 Apr 22;8(16):eabm9987. doi: 10.1126/sciadv.abm9987. Epub 2022 Apr 20.
- Individual participant dataSharing planned: Undecided
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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.
afaf t el nashar, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Endometrial Hyperplasia, run by Sohag 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nermine a abd el fattah, resident doctor (01018254748, nermine_abbas_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of immunohistochemical expression of moesin in endometrial hyperplasia and endometrial carcinoma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619159, which also lists 4 linked publications.
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 16 Nov 2022.