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临床试验/NCT04787159
NCT04787159Unknown不适用

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

Assiut University0 个研究点目标入组 1,000 人开始时间: 2021年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
主要终点
disease free survival at 1 year

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with endometrial cancer, between 2008 and
  • Women should be diagnosed and managed by the corresponding center.
  • Patients with adequate clinical and pathological data.

排除标准

  • Inadequate information and follow-up for at least 5 years.
  • Authorization to use anonymous patient data for research purposes.

结局指标

主要结局

disease free survival at 1 year

时间窗: At 1 year

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

disease free survival at 5 years

时间窗: At 5 years

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

Overall survival at 3 years

时间窗: At 3 years

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

Overall survival at 5 years

时间窗: At 5 years

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

Overall survival at 1 year

时间窗: At 1 year

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

disease free survival at 3 years

时间窗: At 3 years

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherif Abdelkarim Mohammed Shazly

Assistant lecturer

Assiut University

相似试验

Endometrial Cancer International Database | 临床试验