Ovarian NeoplasmsNCT05553067
Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms
An observational study of Ovarian Neoplasms, run by Sohag University at 1 site in Egypt.
Trial summary
Detection of the potential oncogenic role of Engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Immunohistochemical staining of normal and neoplastic ovarian tissues by anti human Engrailed-2 antibody.
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 1 Jun 2022
- 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 20 to 70 years
- Women only
- Adult, Older adult
Study population: This study will be applied on archived formalin-fixed, paraffin embedded ovarian tissue blocks from women who had ovarian benign, borderline and invasive malignant neoplasms and admitted to Obstetrics and Gynecology Department, Sohag University Hospital where they underwent oophorectomy operations because of benign and/ or malignant indications, from 2015 to 2021.
Who may be able to join
- All types of epithelial ovarian neoplasms (benign, borderline and malignant).
Who cannot join
- Non-epithelial and/ or secondary ovarian tumors.
- Cases with poor clinical data.
- Cases who had history of pre-operative chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms.
Detection of the potential oncogenic role of Engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications.
Read the detailed description
Epithelial ovarian carcinomas represent more than 90% of all ovarian carcinomas. Treatment of these ovarian carcinomas on basis of their histopathological features didn't improve patients' outcomes with very high incidence of relapses and resistance to therapy. Detection of novel biological markers which are involved in tumor progression could have promising results if these biological molecules are targeted and blocked by new medications.
Engrailed-2 is a protein encoded by a gene located on chromosome 7. Engrailed-2 is involved in neural development and neural connections during embryological life. it has been proved that Engrailed-2 is expressed in non neural neoplasms, especially in prostatic and urinary bladder carcinomas. Now estimatiion of urinary and serum levels of Engrailed-2 is used as a non-invasive screening tool in to detect prostatic and urinary bladder carcinomas. We aim to evaluated immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues and to compare such expression between normal and neoplastic tissues in order to improve its oncogenic role in ovarian carcinoma.
- Conditions
- Ovarian Neoplasms
- Being tested
- Immunohistochemical staining of normal and neoplastic ovarian tissues by anti human Engrailed-2 antibody.
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical staining of normal and neoplastic ovarian tissues by anti human Engrailed-2 antibody.Genetic
Immunohistochemical staining of normal and neoplastic ovarian tissues by anti human Engrailed-2 antibody and compare levels of expression in different ovarian specimens to detect its potential role in oncogenesis of ovarian carcinoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
compare levels of Engrailed-2 expression in different ovarian specimens.
compare levels of immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues. and correlate Engrailed-2 expression in neoplastic ovarian tissues to patients' ages, tumor phenotype and state of nodal metastasis.
Measured: December, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies 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 (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, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553067
- Sponsor's protocol ID
- Soh-Med-22-09-13
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the participants will share the statistical analysis record and the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms.
- ClinicalTrials.gov ID
- NCT05553067
- Acronym / sponsor ID
- Soh-Med-22-09-13
- Conditions
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 23 Sep 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.
Detection of the potential oncogenic role of Engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications.
Detailed description
Epithelial ovarian carcinomas represent more than 90% of all ovarian carcinomas. Treatment of these ovarian carcinomas on basis of their histopathological features didn't improve patients' outcomes with very high incidence of relapses and resistance to therapy. Detection of novel biological markers which are involved in tumor progression could have promising results if these biological molecules are targeted and blocked by new medications.
Engrailed-2 is a protein encoded by a gene located on chromosome 7. Engrailed-2 is involved in neural development and neural connections during embryological life. it has been proved that Engrailed-2 is expressed in non neural neoplasms, especially in prostatic and urinary bladder carcinomas. Now estimatiion of urinary and serum levels of Engrailed-2 is used as a non-invasive screening tool in to detect prostatic and urinary bladder carcinomas. We aim to evaluated immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues and to compare such expression between normal and neoplastic tissues in order to improve its oncogenic role in ovarian carcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- This study will be applied on archived formalin-fixed, paraffin embedded ovarian tissue blocks from women who had ovarian benign, borderline and invasive malignant neoplasms and admitted to Obstetrics and Gynecology Department, Sohag University Hospital where they underwent oophorectomy operations because of benign and/ or malignant indications, from 2015 to 2021.
Key inclusion criteria (1 listed)
- All types of epithelial ovarian neoplasms (benign, borderline and malignant).
Key exclusion criteria (3 listed)
- Non-epithelial and/ or secondary ovarian tumors.
- Cases with poor clinical data.
- Cases who had history of pre-operative chemotherapy.
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 |
|---|---|---|
| Immunohistochemical staining of normal and neoplastic ovarian tissues by anti human Engrailed-2 antibody.Immunohistochemical staining of normal and neoplastic ovarian tissues by anti human Engrailed-2 antibody and compare levels of expression in different ovarian specimens to detect its potential role in oncogenesis of ovarian carcinoma. | Genetic | – |
Primary outcome
compare levels of Engrailed-2 expression in different ovarian specimens.
Time frame: December, 2021
compare levels of immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues. and correlate Engrailed-2 expression in neoplastic ovarian tissues to patients' ages, tumor phenotype and state of nodal metastasis.
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 27 Sep 2022.
- Individual participant dataSharing planned: Yes. the participants will share the statistical analysis record and the informed consent form.
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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
Sohag University
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 Ovarian Neoplasms, 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 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: finished, as of the sponsor's last update on 27 Sep 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?
compare levels of Engrailed-2 expression in different ovarian specimens. (time frame: December, 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 27 Sep 2022.