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Endometrial Cancer International Database

Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04787159
Acronym
ECID
Enrollment
1000
Registered
2021-03-08
Start date
2021-05-31
Completion date
2022-03-31
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

carcinoma of corpus uteri, uterine malignancy, FIGO staging, adenocarcinoma, lymphadenectomy, hystrectomy, prognosis, prediction, machine learning

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.

Interventions

None listed

Sponsors

Middle-East OBGYN Graduate Education Foundation
CollaboratorOTHER
Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall survival at 1 yearAt 1 yearNumber of women who are alive after cancer treatment divided by total number of patients at study onset
Overall survival at 3 yearsAt 3 yearsNumber of women who are alive after cancer treatment divided by total number of patients at study onset
Overall survival at 5 yearsAt 5 yearsNumber of women who are alive after cancer treatment divided by total number of patients at study onset
disease free survival at 1 yearAt 1 yearNumber of women who are are disease free after cancer treatment divided by total number of patients at study onset
disease free survival at 3 yearsAt 3 yearsNumber of women who are are disease free after cancer treatment divided by total number of patients at study onset
disease free survival at 5 yearsAt 5 yearsNumber of women who are are disease free after cancer treatment divided by total number of patients at study onset

Contacts

Primary ContactSherif A Shazly, M.Sc
sherif.shazly.mogge@gmail.com+15075131392
Backup ContactEsraa M Hosny
esraa.hosny.mogge@gmail.com01112969235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026