NCT04120649

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Typical duration 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

First Submitted

Initial submission to the registry

October 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

October 6, 2019

Last Update Submit

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

Procedure: hysterectomy

Interventions

hysterectomyPROCEDURE

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

endomterial cancer

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

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

Locations