Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma

August 24, 2022 updated by: Ahmed Mohamed Abbas, Assiut University

Comparison Between Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma

Endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in Western countries. Histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. Systematic lymphadenectomy has recently been questioned for stage I disease based on the results from two randomized trials

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients who having endometrial carcinoma

Description

Inclusion Criteria:

  • Not virgin
  • Not having congenital anomalies
  • Early stage
  • Body mass index less than 35

Exclusion Criteria:

  • virgin
  • advanced stage
  • sever infection especially in the pelvis
  • lymphadenopathy for any cause
  • lymphadenectomy for any cause
  • BMI more than 35
  • Synchronous malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endomterial cancer
All patients visiting the clinic at Women Health Hospital who having endometrial carcinoma with their diagnosis based on investigations (tumor marker ) , imaging, histopathology will have surgical staging consisted of total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings
Procedure: hysterectomy
total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the validity of Mayo criteria risk stratification model
Time Frame: 3 months
risk stratification model for prediction of lymph node involvement in women with endometrial carcinoma
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

October 6, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSMLI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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