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NCT04120649 Clinical Trial

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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04120649
Other study ID # RSMLI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2020
Est. completion date August 1, 2022

Study information
Verified date August 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• hysterectomy
total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the validity of Mayo criteria risk stratification model risk stratification model for prediction of lymph node involvement in women with endometrial carcinoma 3 months
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