此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis. (ENDOAT)

2026年9月7日 更新者:Casa di Cura Dott. Pederzoli

Endometriosis "Atypical" and Cancerized: Anatomopathological and Clinical-instrumental Characterization on the Ultrasound and Biological Characteristics of Atypical Endometriosis.

This study hypothesizes that the histological, immunophenotypic, and molecular characterization of atypical endometriotic lesions may be related to specific clinical and ultrasound features.Identifying potentially atypical lesions would allow for more accurate stratification of patients, distinguishing definitely benign from potentially atypical endometriosis.

The targeted study of endometriosis, both typical and atypical, also with reference to the inflammatory microenvironment, as well as immunophenotypic and molecular characteristics, could allow the formulation of pathogenic hypotheses on the development and progression of atypia towards malignant neoplasms.

研究概览

详细说明

Observational, retrospective-prospective, cross-sectional, single-center study conducted on patients undergoing laparoscopic surgery for benign or malignant pathology (endometrial or ovarian). The study does not include changes to the standard care pathway and all procedures are in normal clinical practice. The indication for surgical treatment is formulated on the basis of the most up-to-date guidelines on the subject. The study includes two phases:

  • Single-center observational retrospective study with case collection starting June 2024
  • Single-center prospective observational study with recruitment of new cases for 30 months after the start of the project.

At the time of the pre-hospitalization visit, the patient will be clearly and understandably illustrated with the rationale and objective of the study, the planned procedures (which do not deviate from normal clinical practice) and the data that are intended to be collected for each patient. There are four groups under comparison: patients with endometriosis without atypia and patients with neoplasia not associated with endometriosis represent the "controls", while patients with atypical endometriosis and patients with cancerized endometriosis or neoplasia associated with endometriosis represent the "cases". Patients with ovarian / endometrial neoplasia not associated with endometriosis will serve as a control for both the ultrasound appearance of the lesions and for anatomopathological analysis (including immunohistochemical and molecular investigations).

Patients included in the study will undergo a level II gynecological ultrasound with transvaginal technique by experienced operators, the images will be reviewed by two experienced operators.

Patients will be operated on by operators experienced in endometriosis surgery. The anatomopathological diagnostic report will be structured sec. International Collaboration on Cancer Reporting (ICCR) (Annexes 1 and 2), which includes essential elements ("core"), and optional elements ("non-core") (https://www.iccr-cancer.org/).

Each case will be evaluated individually and then in doubles by two anatomopathologists experienced in gynecological pathology.

The immunohistochemical and molecular panel are routinely performed in patients with atypical endometriosis, cancerized endometriosis, or endometriosis-associated neoplasia and in neoplasms not associated with endometriosis, therefore the performance of these procedures does not deviate from such clinical practice. In patients with endometriosis "typical", a reduced panel will be performed, if deemed necessary by the pathologist, particularly if there are dubious morphological pictures.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Verona
      • Peschiera del Garda、Verona、意大利、37019
        • 招聘中
        • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

patients undergoing laparoscopic surgery for benign or malignant (endometrial or ovarian) pathology

描述

Inclusion Criteria:

  • Age > 18 years
  • Candidate patients for endometriosis surgery with deep endometriosis (intestine, LUS) and/or endometrioma localizations.
  • Patients who are candidates for surgery for established or suspected endometrial and/or ovarian neoplasm
  • Patients who have performed a level II gynecological ultrasound with an experienced operator in the preoperative process.
  • Patients where there is the technical possibility of performing a transvaginal and/or transrectal ultrasound and the patient's willingness to undergo such an investigation.
  • Signing of informed consent.

Exclusion Criteria:

  • Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
  • Previous neoplasms
  • Patient who does not provide their informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
prospective observational group
Single-center prospective observational study with recruitment of new cases for 30 months from the start of the project.
retrospective observational group
Single-center observational retrospective study with case collection starting June 2024

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Identification of specific histopathological, immunohistochemical and molecular biology features for definable "atypical", "preneoplastic" or "cancerized-neoplastic" lesions and the surrounding microenvironment
大体时间:through study completion, an average of 1 year
through study completion, an average of 1 year

次要结果测量

结果测量
大体时间
Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"
大体时间:through study completion, an average of 1 year
through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2029年1月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年9月7日

首先提交符合 QC 标准的

2026年9月7日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅