Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
Comparison Between Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
1 other identifier
observational
50
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedAugust 25, 2022
August 1, 2022
2 years
October 6, 2019
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the validity of Mayo criteria risk stratification model
risk stratification model for prediction of lymph node involvement in women with endometrial carcinoma
3 months
Study Arms (1)
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
Interventions
total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings
Eligibility Criteria
patients who having endometrial carcinoma
You may qualify if:
- Not virgin
- Not having congenital anomalies
- Early stage
- Body mass index less than 35
You may not qualify if:
- virgin
- advanced stage
- sever infection especially in the pelvis
- lymphadenopathy for any cause
- lymphadenectomy for any cause
- BMI more than 35
- Synchronous malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed Abbas
Assiut, Cairo Governorate, 002, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 9, 2019
Study Start
May 18, 2020
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
August 25, 2022
Record last verified: 2022-08