Brief Title
Endometrial Cancer International Database
Official Title
Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study
Brief Summary
This project aims to determining prognostic factors and individualizing management decision
per patient characteristics and endometrial cancer features. This study will include at least
10 centers from different countries that present at least Europe, South America, Asia, and
Africa. Data will be retrospectively collected from January 2008 to December 2015 with a
total follow-up of at least 5 years (December 2020).
Detailed Description
Endometrial cancer (EC) or carcinoma of corpus uteri is a neoplastic change, mostly
adenocarcinoma, arising from uterine columnar epithelial lining. Abnormal uterine bleeding is
the main presenting symptom especially in postmenopausal women. EC is estimated to be the
seventh most commonly diagnosed cancer in women. It is considered the 16th leading cause of
death in women with cancer worldwide, with 382 000 estimated new cases and 89 900 deaths in
2018. Factors as obesity, parity, diabetes mellitus, unopposed estrogen exposure, genetics
and hormonal therapies are recognizable risks for EC. Other factors as chronic comorbidities,
tumor size and organ metastasis influence staging, prognosis, and management protocols.
FIGO staging has been adopted as the standard classification system in the management of
endometrial cancer. However, this staging system does not consider all factors that affect
treatment decision and prognosis including but not limited to patient demographics, tumor
grade, and lymphovascular space invasion. In addition, some interventions are still debatable
particularly in the presence of intermediate disease e.g, grade II early EC. Available
evidence supports combined pelvic and para-aortic lymphadenectomy in management of patients
with EC. However, combined pelvic and para-aortic lymphadenectomy carry the risk of long term
morbidities as lymphedema. Thus, hysterectomy alone as management plan is suggested in
patients with low risk EC. More comprehensive studies of the multiple confounders that
determine patient's risk are essential to reach an individually adjusted management plans and
to predict prognosis of each individual case. Therefore, availability of large multicenter
studies will provide robust evidence regarding optimal management of EC and hence, improve
treatment outcome and prognosis particularly in the era of machine learning and artificial
intelligence.
Study Type
Observational
Primary Outcome
Overall survival at 1 year
Condition
Endometrial Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
May 2021
Completion Date
March 2022
Primary Completion Date
December 2021
Eligibility Criteria
Inclusion Criteria:
- Women diagnosed with endometrial cancer, between 2008 and 2015.
- Women should be diagnosed and managed by the corresponding center.
- Patients with adequate clinical and pathological data.
Exclusion Criteria:
- Inadequate information and follow-up for at least 5 years.
- Authorization to use anonymous patient data for research purposes.
Gender
Female
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Sherif A Shazly, M.Sc, +15075131392, [email protected]
Administrative Informations
NCT ID
NCT04787159
Organization ID
EC-ID21
Responsible Party
Principal Investigator
Study Sponsor
Assiut University
Collaborators
Middle-East OBGYN Graduate Education Foundation
Study Sponsor
Sherif A Shazly, M.Sc, Principal Investigator, Assiut University
Verification Date
March 2021