NCT06148129

Brief Summary

The incidence of endometrial cancer (EC) is increasing .Different risk classifications are used to direct the primary and adjuvant therapy. The European Society for Medical Oncology - European Society of Gynaecological Oncology -European Society for Radiotherapy \& Oncology (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also post-operatively to determine adjuvant treatment. Low-risk patients are managed with surgery alone, while higher-risk group patients undergo more aggressive surgical options. So, it is important to identify new prognostic markers for better stratification of patients to avoid under- or over treatment of EC patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

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 12, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

November 13, 2023

Last Update Submit

November 27, 2023

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • expression levels of p53/L1CAM/ER/PR

    The Prognostic value of immunohistochemical detection of expression levels of p53/L1CAM/ER/PR in relation to ESMO-ESGO-ESTRO risk groups

    36 Months

Study Arms (2)

Study group

ACTIVE COMPARATOR
Diagnostic Test: Tissue Biopsy

Excluded Patients

NO INTERVENTION

Interventions

Tissue BiopsyDIAGNOSTIC_TEST

The Post-hysterectomy tissue biopsy was analyzed immunohistochemically for detection of estrogen and progesterone receptors, P53 and L1CAM

Study group

Eligibility Criteria

Age36 Years - 72 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 36 -72 years;
  • Previously diagnosed with endometrial carcinoma;
  • Histological Type of the tumor;
  • Myometrial Invasion;
  • lymph Node Invasion;
  • Cervical Invasion;
  • Biomarkers expression.

You may not qualify if:

  • Lack of tumor tissue in tissue block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of gynecology

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 28, 2023

Study Start

January 12, 2019

Primary Completion

October 1, 2021

Study Completion

March 1, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

EG(1)