Endometrial HyperplasiaNCT04873206
Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies
An observational study of Endometrial Hyperplasia and Endometrial Adenocarcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
endometrial hyperplasia may progress to endometrial adenocarcinoma. the exact possibility of such progression is not determined. there a need to detect biological markers that can help in detecting high risk cases of patients with endometrial hyperplasia that may progress to endometrial adenocarcinoma. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Hyperplasia, Endometrial Adenocarcinoma
- What is being tested?
- routine stain by H&E.
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: endometrial specimens and hystrectomy operations will be done in Gyn\&Obs Department of Sohag University Hospital and will be prepared in formalin-fixed, Parraffin-embedded blocks. endometrial blocks will be sectioned and stained by H\&E stain. from the same blocks, corresponding tissue sections will be staine immunohistochemically by anti-human PTEN antibodies.
Who may be able to join
- all cases of endometrial biopsies and hystrectomy specimens diagnosed as endometrial hyperplasia and/or primary endometrial adenocarcinoma.
- all cases of normal endometrium obtained from hystrectomy specimens due to other pathological conditions as prolapsed uteri, uterine leiomyoma and adenomyosis.
Who cannot join
- autolysed samples, very tiny specimens cervical tissues and specimens with histological picture of endometritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies.
endometrial hyperplasia may progress to endometrial adenocarcinoma. the exact possibility of such progression is not determined. there a need to detect biological markers that can help in detecting high risk cases of patients with endometrial hyperplasia that may progress to endometrial adenocarcinoma. PTEN is a tumor suppressor gene that inhibit cell migration, proliferation and may induce apoptosis in damaged cells. variable expression of PTEN in functional, hyperplastic and neoplastic endometrial tissues may be of great help in detecting cases of hyperplasia that may progress to endometrial adenocarcinoma.
Read the detailed description
Adenocarcinoma of the endometrium is the most prevalent invasive tumor of female genital tract. Endometrial carcinoma is divided to 2 different types as regards to genitical and phenotypical features, type I endometrial carcinoma represents more than three quarters of all cases. Type I is inevitably preceded by hyperplastic changes in the endometrium. However, the malignant potential of endometrial hyperplasia to carcinoma is markedly variable and subjected to interobserver variations. Determine of novel biological markers for detection of precancerous endometrial hyperplasia that may proceed to endometrial adenocarcinoma is a must. PTEN is a tumor suppressor gene. it inhibits cell mitosis and migration. PTEN induce the damaged cells to pass in apoptosis. Low levels of PTEN expression noted in many human malignancies as melanoma, mammary and ovarian carcinomas.
The aim of this study is to evaluate the expression of PTEN (by immunohistochemistry) in different endometrial biological conditions as endometrial hyperplasia and primary endometrial adenocarcinoma specimens, and correlate that expression to PTEN expression in physiological endometrial specimens.
- Being tested
- routine stain by H&E.
- Keywords
- PTEN., Endometrial Hyperplasia., Endometrial Carcinoma
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine stain by H&E.Other
Also called Immunohistochemistry.
formalin fixed, Parraffin embedded endometrial tissues will be sectioned and get stained by the routine Haematoxalin and Eosin stain in addition to immunohistochemical staining by anti-human PTEN antibody.
| Study group | Role | What they receive |
|---|---|---|
| Functional/ Cyclical Endometrial group. | cases of normal endometrium will be obtained from hystrectomy specimens done for causes other than hyperplasia or adenocarcinoma, for example; uterine fibroids, uterine prolapse. Receives: Other: routine stain by H&E. | |
| Hyperplastic Endometrial group. | cases of endometrial hyperplasia obtained by D\&C or hystrectomy will be stained by H\&E stain and categorized into typical or atypical hyperplasia. Receives: Other: routine stain by H&E. | |
| Primary Endometrial Adenocarcinoma group. | cases of primary endometrial adenocarcinoma obtained by D\&C or hystrectomy operations Receives: Other: routine stain by H&E. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies.
cases of primary endometrial carcinoma and complex endometrial hyperplasia should express mutant form of PTEN compared to functional and simple hyperplastic endometrial tissues.
Measured: June, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Hashem Mohammed, Sohag University
- Investigators
- Maisa H Mohammed, MD, Principal investigator, a lecturer of pathology, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873206
- Sponsor's protocol ID
- Soh-Med-21-04-29
- Status last verified
- Jul 2022
- First submitted
- 30 Apr 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies.
- ClinicalTrials.gov ID
- NCT04873206
- Acronym / sponsor ID
- Soh-Med-21-04-29
- Keywords
- PTEN., Endometrial Hyperplasia., Endometrial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 May 2021 (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 hyperplasia may progress to endometrial adenocarcinoma. the exact possibility of such progression is not determined. there a need to detect biological markers that can help in detecting high risk cases of patients with endometrial hyperplasia that may progress to endometrial adenocarcinoma. PTEN is a tumor suppressor gene that inhibit cell migration, proliferation and may induce apoptosis in damaged cells. variable expression of PTEN in functional, hyperplastic and neoplastic endometrial tissues may be of great help in detecting cases of hyperplasia that may progress to endometrial adenocarcinoma.
Detailed description
Adenocarcinoma of the endometrium is the most prevalent invasive tumor of female genital tract. Endometrial carcinoma is divided to 2 different types as regards to genitical and phenotypical features, type I endometrial carcinoma represents more than three quarters of all cases. Type I is inevitably preceded by hyperplastic changes in the endometrium. However, the malignant potential of endometrial hyperplasia to carcinoma is markedly variable and subjected to interobserver variations. Determine of novel biological markers for detection of precancerous endometrial hyperplasia that may proceed to endometrial adenocarcinoma is a must. PTEN is a tumor suppressor gene. it inhibits cell mitosis and migration. PTEN induce the damaged cells to pass in apoptosis. Low levels of PTEN expression noted in many human malignancies as melanoma, mammary and ovarian carcinomas.
The aim of this study is to evaluate the expression of PTEN (by immunohistochemistry) in different endometrial biological conditions as endometrial hyperplasia and primary endometrial adenocarcinoma specimens, and correlate that expression to PTEN expression in physiological endometrial specimens.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional/ Cyclical Endometrial group. | – | Other: routine stain by H&E.cases of normal endometrium will be obtained from hystrectomy specimens done for causes other than hyperplasia or adenocarcinoma, for example; uterine fibroids, uterine prolapse. |
| Hyperplastic Endometrial group. | – | Other: routine stain by H&E.cases of endometrial hyperplasia obtained by D\&C or hystrectomy will be stained by H\&E stain and categorized into typical or atypical hyperplasia. |
| Primary Endometrial Adenocarcinoma group. | – | Other: routine stain by H&E.cases of primary endometrial adenocarcinoma obtained by D\&C or hystrectomy operations |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- endometrial specimens and hystrectomy operations will be done in Gyn\&Obs Department of Sohag University Hospital and will be prepared in formalin-fixed, Parraffin-embedded blocks. endometrial blocks will be sectioned and stained by H\&E stain. from the same blocks, corresponding tissue sections will be staine immunohistochemically by anti-human PTEN antibodies.
Key inclusion criteria (2 listed)
- all cases of endometrial biopsies and hystrectomy specimens diagnosed as endometrial hyperplasia and/or primary endometrial adenocarcinoma.
- all cases of normal endometrium obtained from hystrectomy specimens due to other pathological conditions as prolapsed uteri, uterine leiomyoma and adenomyosis.
Key exclusion criteria (1 listed)
- autolysed samples, very tiny specimens cervical tissues and specimens with histological picture of endometritis.
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 |
|---|---|---|
| routine stain by H&E.Also: Immunohistochemistry.formalin fixed, Parraffin embedded endometrial tissues will be sectioned and get stained by the routine Haematoxalin and Eosin stain in addition to immunohistochemical staining by anti-human PTEN antibody. | Other | Functional/ Cyclical Endometrial group., Hyperplastic Endometrial group., Primary Endometrial Adenocarcinoma group. |
Primary outcome
Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies.
Time frame: June, 2021
cases of primary endometrial carcinoma and complex endometrial hyperplasia should express mutant form of PTEN compared to functional and simple hyperplastic endometrial tissues.
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 Jul 2022.
- 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.
Maisa H Mohammed, MD principal investigator
a lecturer of pathology, Sohag faculty of medicine
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 Hyperplasia and Endometrial Adenocarcinoma, 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 2 inclusion and 1 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 Jul 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?
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?
Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies. (time frame: June, 2021). 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 Jul 2022.