Clinical trial NCT04787159: Endometrial Cancer International Database
Official title: Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Keywords: carcinoma of corpus uteri
uterine malignancy
FIGO staging
adenocarcinoma
lymphadenectomy
hystrectomy
prognosis
prediction
machine learning
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Middle-East OBGYN Graduate Education Foundation
First posted: 2021-03-08
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who were diagnosed with endometrial cancer at any stage, of all histological types and grades, between 2008 and 2015.

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.

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.

Primary outcomes:
measure: Overall survival at 1 year
timeFrame: At 1 year
measure: Overall survival at 3 years
timeFrame: At 3 years
measure: Overall survival at 5 years
timeFrame: At 5 years
measure: disease free survival at 1 year
timeFrame: At 1 year
measure: disease free survival at 3 years
timeFrame: At 3 years
measure: disease free survival at 5 years
timeFrame: At 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Sherif A Shazly, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bell DW, Ellenson LH. Molecular Genetics of Endometrial Carcinoma. Annu Rev Pathol. 2019 Jan 24;14:339-367. doi: 10.1146/annurev-pathol-020117-043609. Epub 2018 Oct 17.
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citation: Hamilton CA, Pothuri B, Arend RC, Backes FJ, Gehrig PA, Soliman PT, Thompson JS, Urban RR, Burke WM. Endometrial cancer: A society of gynecologic oncology evidence-based review and recommendations, part II. Gynecol Oncol. 2021 Mar;160(3):827-834. doi: 10.1016/j.ygyno.2020.12.024. Epub 2021 Jan 13.
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citation: Raglan O, Kalliala I, Markozannes G, Cividini S, Gunter MJ, Nautiyal J, Gabra H, Paraskevaidis E, Martin-Hirsch P, Tsilidis KK, Kyrgiou M. Risk factors for endometrial cancer: An umbrella review of the literature. Int J Cancer. 2019 Oct 1;145(7):1719-1730. doi: 10.1002/ijc.31961. Epub 2019 Feb 20.
citation: Kruse AJ, Ter Brugge HG, de Haan HH, Van Eyndhoven HW, Nijman HW. Vaginal hysterectomy with or without bilateral salpingo-oophorectomy may be an alternative treatment for endometrial cancer patients with medical co-morbidities precluding standard surgical procedures: a systematic review. Int J Gynecol Cancer. 2019 Feb;29(2):299-304. doi: 10.1136/ijgc-2018-000015. Epub 2019 Jan 18.
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citation: Petousis S, Christidis P, Margioula-Siarkou C, Papanikolaou A, Dinas K, Mavromatidis G, Guyon F, Rodolakis A, Vergote I, Kalogiannidis I. Combined pelvic and para-aortic is superior to only pelvic lymphadenectomy in intermediate and high-risk endometrial cancer: a systematic review and meta-analysis. Arch Gynecol Obstet. 2020 Jul;302(1):249-263. doi: 10.1007/s00404-020-05587-2. Epub 2020 May 28.
citation: Mariani A, Webb MJ, Keeney GL, Haddock MG, Calori G, Podratz KC. Low-risk corpus cancer: is lymphadenectomy or radiotherapy necessary? Am J Obstet Gynecol. 2000 Jun;182(6):1506-19. doi: 10.1067/mob.2000.107335.
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