NCT05553067

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

7 years

First QC Date

September 21, 2022

Last Update Submit

September 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    December, 2021

Interventions

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.

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All types of epithelial ovarian neoplasms (benign, borderline and malignant).

You may not qualify if:

  • Non-epithelial and/ or secondary ovarian tumors.
  • Cases with poor clinical data.
  • Cases who had history of pre-operative chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Maisa H Mohammed, MD

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pathology

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

January 1, 2015

Primary Completion

December 31, 2021

Study Completion

June 1, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

the participants will share the statistical analysis record and the informed consent form.

Shared Documents
SAP, ICF
Time Frame
within six months after publication.
Access Criteria
the principle investigator will share the statistical analysis record and the informed consent form on her account on research gate.
More information

Locations