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ECID: Endometrial Cancer International Database

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04787159
Collaborator
Middle-East OBGYN Graduate Education Foundation (Other)
1,000
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study
    Anticipated Study Start Date :
    May 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival at 1 year [At 1 year]

      Number of women who are alive after cancer treatment divided by total number of patients at study onset

    2. Overall survival at 3 years [At 3 years]

      Number of women who are alive after cancer treatment divided by total number of patients at study onset

    3. Overall survival at 5 years [At 5 years]

      Number of women who are alive after cancer treatment divided by total number of patients at study onset

    4. disease free survival at 1 year [At 1 year]

      Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

    5. disease free survival at 3 years [At 3 years]

      Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

    6. disease free survival at 5 years [At 5 years]

      Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University
    • Middle-East OBGYN Graduate Education Foundation

    Investigators

    • Principal Investigator: Sherif A Shazly, M.Sc, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sherif Abdelkarim Mohammed Shazly, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04787159
    Other Study ID Numbers:
    • EC-ID21
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sherif Abdelkarim Mohammed Shazly, Assistant lecturer, Assiut University
    carcinoma of corpus uteri
    uterine malignancy
    FIGO staging
    adenocarcinoma
    lymphadenectomy
    hystrectomy
    prognosis
    prediction
    machine learning
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Mar 9, 2021