Variable Endometrial LesionsNCT06132230
Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
An observational study of Variable Endometrial Lesions, run by Sohag University at 1 site in Egypt.
Trial summary
Endometrial carcinoma (EC) is the 6th most commonly occurring cancer in women and the 15th most common cancer overall According to facts derived from Globocan for the year 2020.The overall incidence was 417,367 and 97,370 died due to it. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Variable Endometrial Lesions
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2023to Dec 2025
- 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 25 to 80 years
- Women only
- Adult, Older adult
Study population: Formalin-fixed paraffin blocks from 70 patients
Who may be able to join
- 1. Specimens of total abdominal hysterectomy and bilateral salpingio-oopherectomy of endometrial carcinoma patients 2. D\&C of endometrial tissue suspected of hyperplastic or neoplastic lesions
Who cannot join
- • Specimens with insufficient clinical data.
- Specimens with extensive necrosis
Trial locations and contacts
1 site in 1 country.
Gehad Bahgat contact
About this study
Endometrial carcinoma (EC) is the 6th most commonly occurring cancer in women and the 15th most common cancer overall According to facts derived from Globocan for the year 2020.The overall incidence was 417,367 and 97,370 died due to it. There were more than 417,000 new cases of endometrial cancer in 2020 .EC incidence is predicted to continue to rise in the coming decades, in particular among low and middle-income countries.
SOX17 protein (SRY-box 17) is a member of the SRY-related HMG-box (SOX) family of transcription factors that controls the first step of gene expression and regulates cellular growth and differentiation in the endoderm, during hematopoiesis, and in the cardiovascular system E-Cadherin is a calcium-dependent cell adhesion protein (predicted molecular weight of 97 kDa) that plays a vital role in cell migration and proliferation. The E-cadherin epithelial cell adhesion protein is a tumor suppressor that has an important role in tumor metastasis The loss of expression of E-Cadherin during the epithelial mesenchymal transition (EMT) is often thought to promote metastasis by allowing the dissociation and invasion of cancer cells
Read more
The aim of this study is:
- To evaluate accuracy of SOX17 expression in neoplastic and hyperplastic endometrial lesions.
- To correlate SOX17 expression with some clinical and pathological parameters of endometrial carcinoma.
- To evaluate E-Cadhrin expression and its relation to SOX17 in neoplastic and hyperplastic lesions
- Conditions
- Variable Endometrial Lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
Immunohistochemical expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
Measured: one or two days after staining sections with markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variable Endometrial LesionsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Bahgat Abdelhameed, Sohag University
- Investigators
- Gehad Bahgat, Principal investigator, Sohag faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132230
- Sponsor's protocol ID
- Soh-Med-10-11MD
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
- ClinicalTrials.gov ID
- NCT06132230
- Acronym / sponsor ID
- Soh-Med-10-11MD
- Conditions
- Variable Endometrial Lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Nov 2023 (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 6th most commonly occurring cancer in women and the 15th most common cancer overall According to facts derived from Globocan for the year 2020.The overall incidence was 417,367 and 97,370 died due to it. There were more than 417,000 new cases of endometrial cancer in 2020 .EC incidence is predicted to continue to rise in the coming decades, in particular among low and middle-income countries.
SOX17 protein (SRY-box 17) is a member of the SRY-related HMG-box (SOX) family of transcription factors that controls the first step of gene expression and regulates cellular growth and differentiation in the endoderm, during hematopoiesis, and in the cardiovascular system E-Cadherin is a calcium-dependent cell adhesion protein (predicted molecular weight of 97 kDa) that plays a vital role in cell migration and proliferation. The E-cadherin epithelial cell adhesion protein is a tumor suppressor that has an important role in tumor metastasis The loss of expression of E-Cadherin during the epithelial mesenchymal transition (EMT) is often thought to promote metastasis by allowing the dissociation and invasion of cancer cells
The aim of this study is:
- To evaluate accuracy of SOX17 expression in neoplastic and hyperplastic endometrial lesions.
- To correlate SOX17 expression with some clinical and pathological parameters of endometrial carcinoma.
- To evaluate E-Cadhrin expression and its relation to SOX17 in neoplastic and hyperplastic lesions
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Formalin-fixed paraffin blocks from 70 patients
Key inclusion criteria (1 listed)
- 1. Specimens of total abdominal hysterectomy and bilateral salpingio-oopherectomy of endometrial carcinoma patients 2. D\&C of endometrial tissue suspected of hyperplastic or neoplastic lesions
Key exclusion criteria (2 listed)
- • Specimens with insufficient clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
Time frame: one or two days after staining sections with markers
Immunohistochemical expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
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.
Gehad Bahgat contact
Gehad Bahgat principal investigator
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 Variable Endometrial Lesions, 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 1 inclusion and 2 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 15 Nov 2023. 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 Gehad Bahgat (01114852233, gehadbahgat94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions (time frame: one or two days after staining sections with markers). 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 Nov 2023.