The Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population (ENDOCancerDATA)
The ENDOCancer-DATA: the Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population
研究概览
详细说明
Endometrial cancer represents the most common gynecological cancer in industrialized countries and the fourth most common neoplasm after breast, lung and colorectal cancer. Unlike other neoplasms, its incidence and mortality are continuously increasing. In this context, the National Health System requires an optimization of the diagnosis and treatment strategies of this carcinoma. This aspect leads a continuous effort to improve to properly manage the impact that this disease has on female health in Italy. Throughout the world, there are national, supranational models and registers aimed at establishing and managing over time an archive of all newly diagnosed cancer cases, ensuring that data recording takes place in a rigorous, continuous and systematic manner. An excellent example of this is the SEER of the National Cancer Institute of America, which has the task of recording and monitoring the epidemiological-clinical data of various carcinomas, to monitor the clinical progress and management of therapeutic programs of neoplastic pathologies. This program represents the epidemiological and statistical basis of important scientific evidence, both prospective and retrospective, aimed at reporting and demonstrating the effectiveness of preventive, diagnostic and therapeutic approaches in the various oncological pathologies examined.
On these premises, the aim of this study is to lay the bases for an ambitious project that reports and records all the epidemiological-clinical information of the cases of endometrial carcinoma diagnosed and treated in the reference oncology centers involved on the national territory, to create a process of analysis of the data
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Francesco Fanfani, MD
- 电话号码:+390630133421
- 邮箱:francesco.fanfani@policlinicogemelli.it
学习地点
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Roma、意大利、00136
- 招聘中
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
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接触:
- Francesco Fanfani, MD
- 电话号码:0630153421
- 邮箱:francesco.fanfani@policlinicogemelli.it
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
All patients undergoing staging and cytoreduction surgery for endometrial cancer will be included in the study.
This database will make use of data collected retrospectively with prospectively continuously updated prognostic and clinical information.
The following data will be collected: clinical characteristics (age, BMI, ASA, previous tumors), histopathological data (histotype, grade, FIGO stage, etc.) Furthermore, data will be collected relating to the adjuvant chemotherapy or radiotherapy treatment performed, survival outcome (DFS and OS), number of relapses and deaths, type of relapse, treatment at relapse, cause of death.
描述
Inclusion Criteria:
- diagnosis of endometrial cancer (stage I-IV, G1-3, and special histotypes)
- age > 18 years
- American Society of Anesthesiologists classification (ASA score) 1-3
- patients undergoing staging, cytoreduction or diagnostic surgery with acquisition of histological examination on which IHC and/or NGS studies have been performed for the molecular profile of the carcinoma
- Signed informed consent
Exclusion Criteria:
- patients with missing information
- patients not treated in the participating centers for which only partial and fragmented information will be available
- molecular profile not known and\or not recoverable and retrospectively analysable
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Endometrial cancer patients
All patients undergoing staging and cytoreduction surgery for endometrial cancer
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Disease Free Survival
大体时间:Baseline.
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To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of DFS (Disease-Free Survival).
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Baseline.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival
大体时间:Baseline.
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To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of OS (overall survival).
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Baseline.
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合作者和调查者
调查人员
- 首席研究员:Francesco Fanfani、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 6168
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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