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临床试验/NCT04290299
NCT04290299招募中不适用

Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

National Cancer Institute, Naples19 个研究点 分布在 16 个国家目标入组 100 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
19
主要终点
Pattern of relapse

研究概览

简要总结

Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility.

The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up.

Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.

详细描述

PURPOSE The goal of this research project is to learn more about the safety of conservatively treating EC and about subsequent fertility outcome.

PROJECT TYPE Observational (patient archive) - The project runs within the framework of Gynecologic Cancer InterGroup (GCIG), thus, participating Centres must belong to one of the qualified National groups.

PROJECT DESIGN Observational model: Cohort

TIME PERSPECTIVE Prospective

ENDPOINT CLASSIFICATION Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Informed consent to personal data processing
  • Existence of an IRB-approved local protocol that allows conservative treatment to be performed or statement that such treatment is considered as a standard (please note that such protocols should be shared with the database owner National Cancer Institute of Naples).

排除标准

  • 未提供

结局指标

主要结局

Pattern of relapse

时间窗: 10 years

Tumor-related deaths

时间窗: 10 years

Frequency of relapse

时间窗: 10 years

Proportion of complete regression

时间窗: 10 years

Duration of response

时间窗: 10 years

Frequency of metachronous ovarian cancer

时间窗: 10 years

次要结局

  • Treatment related morbidity(10 years)
  • Frequency of spontaneous pregnancies(10 years)
  • Frequency of pregnancies after ART(10 years)
  • Frequency of residual disease on definitive surgical specimens(10 years)

研究者

发起方
National Cancer Institute, Naples
申办方类型
Other
责任方
Sponsor

研究点 (19)

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