- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120649
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
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
-
-
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
|
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
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.
Clinical Trials on Endometrial Cancer
-
Assistance Publique - Hôpitaux de ParisUniversité Montpellier; Ecole d'econmie de Paris (PSE)-Hospinnomics; Université...CompletedEndometrial Cancer Stage I | Endometrial Cancer Stage IIFrance
-
Radboud University Medical CenterMaastricht University Medical Center; Erasmus Medical Center; Catharina Ziekenhuis... and other collaboratorsRecruitingEndometrial Cancer Recurrent | Endometrial Cancer Stage III | Endometrial Cancer Stage IVNetherlands
-
Batman Training and Research HospitalEskisehir Osmangazi UniversityCompletedGynecologic Cancer | Endometrial Cancer Stage
-
Samsung Medical CenterRecruitingEndometrial Cancer Stage IKorea, Republic of
-
Duke UniversityDuke Cancer InstituteCompleted
-
Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial CancerChina
-
Novartis PharmaceuticalsCompletedAdvanced Endometrial CancerBelgium, France, Italy, Canada, Spain, Australia, Germany, United States, Japan, Brazil, Singapore, Russian Federation, Poland
-
Masonic Cancer Center, University of MinnesotaCompletedCervical Cancer | Ovarian Cancer | Uterine Endometrial CancerUnited States
-
Rambam Health Care CampusCompletedSerous Papillary Endometrial CancerIsrael
Clinical Trials on hysterectomy
-
Southern Medical University, ChinaRecruiting
-
Queensland Centre for Gynaecological CancerNational Health and Medical Research Council, Australia; Johnson & Johnson... and other collaboratorsCompletedEndometrial CancerUnited Kingdom, Australia, Hong Kong, New Zealand
-
University Hospital, GhentCompletedOutpatient Hysterectomy in TransmenBelgium
-
University of Texas Southwestern Medical CenterCompletedEndometriosis | Pelvic Pain | Adenomyosis | Metrorrhagia | Pelvic Inflammatory Disease | Leiomyoma | MenorrhagiaUnited States
-
Nykøbing Falster County HospitalZealand University Hospital; Rigshospitalet, Denmark; University of Southern...Completed
-
Hospital Universitari Vall d'Hebron Research InstituteCompletedSurgery--Complications
-
Mansoura UniversityCompleted
-
Mayo ClinicTerminated
-
Chen ChunlinUnknownCervical CancerChina
-
Imelda Hospital, BonheidenCompleted