跳至主要内容
临床试验/NCT07558889
NCT07558889招募中不适用

The ENDOCancer-DATA: the Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Disease Free Survival

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Endometrial cancer patients

All patients undergoing staging and cytoreduction surgery for endometrial cancer

结局指标

主要结局

Disease Free Survival

时间窗: Baseline.

To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of DFS (Disease-Free Survival).

次要结局

  • Overall Survival(Baseline.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Surveillance, Epidemiology, and End Results... | 临床试验