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临床试验/NCT06623916
NCT06623916已完成不适用

Can Elastographic Evaluation Be a New Approach in Prediction of Endometrial Cancer Prognostic Markers?

Alper seyhan1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
feasibility; to compare the stiffness and strain character of tumor tissue with well-known pathological prognostic factors of endometrial cancer.

研究概览

简要总结

Strain elastography is a novel, non-invasive, easy applicable method to determine the tissue characteristics of benign or malign lesions in various organs. In this preliminary prospective study, we investigated the relation between the known pathological prognostic factors of endometrial cancer and elastographic characteristics of tumor tissue

详细描述

Endometrial cancer is the most common gynecologic cancer, particularly in developed countries of the World. Today, it ranks as the 4th most common cancer among the women after breast, colorectal and lung malignencies. Although 4% of patients are premenopausal, most common symptom of disease is postmenopausal bleeding. Obtaining pathological sample as an endometrial Pipelle Biopsy, dilatation-curettage or hysterescopic excision are main diagnostic methods in endometrial cancer. Prognosis of disease depends on age, grade, myometrial invasion-histologic type of tumor, lymph node and distant metastasis.

In addition to pathologic reports; transvaginal ultrasound is most commonly used preoperative non invasive, no radiation-related and low cost imaging method to assess the endometrial cavity, endo-myometrial invasion, tumor diameter, cervical and adnexal involvement. Some of these risk factors can be easily detected with transvaginal ultrasound as well as intraoperative frozen-section examination.

Sonoelastography is a novel technique, which evaluate tissue stiffness both qualitatively and quantitatively and can distinguish different lesions in various organs as liver, breast and thyroid. Strain and shear-wave imagings are two main elastographic technics that commonly used with ultrasound technology. In the first method, the operator exerts manual compression on the tissue with the ultrasound transducer. Strain elastography evaluates the tissue elasticity by measuring the degree of distorsion by the compression and decompression of soft tissues and strain ratio (SR) is obtained by proportioning the tissue elasticity of the suspicious pathologic area with a reference point. Manual compression works fairly well for superficial organs such as the breast, superficial lymph nodes and thyroid but is challenging for assessing elasticity in deeper located organs such as the liver. Strain elastography is a semi-quantitative method due to the variations in compression and decompression pressures and selected ROI areas between practitioners. The use of SR makes this relative subjective technic more objective. In shear wave elastography, the ultrasound transducer is held steady, and tissue displacement is generated by internal physiologic motion (e.g. cardiovascular, respiratory). Since this method is not dependent on superficially applied compression, variations between practitioners are negligible and it may be used to assess deeper located organs.

In gynecology clinical practice, sono elastography has been used in recent years in different subjects as ovarian and endometrial benign lesions. In diagnostic process, elastography is not been well established in endometrial cancer.

In this study, we aimed to determine whether sonoelastography could be a new prognostic predictor in endometrial cancer. Accordingly, we examined the relationship between the elastographic features of the lesions and known pathologic prognostic factors in endometrial cancer cases.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients with epitheliel endometrial cancer diagnosis with biopsy.

排除标准

  • Diagnosis of different types of tumors in the last 5 years
  • Presence of synchronous malignancy, presence of non epithelial uterine tumor
  • Lack of patient data
  • Presence of full-thickness uterine and cervical involvement (lack of evaluation for elastography)
  • Lack of patient compliance for transvaginal ultrasound
  • Inoperable cases (lack of definitive pathologic report)

结局指标

主要结局

feasibility; to compare the stiffness and strain character of tumor tissue with well-known pathological prognostic factors of endometrial cancer.

时间窗: strain ratio measurements of tumor tissue were performed one night before the operation. these data were compared with pathological reports which results 1 month after the cytoreductive surgery.

The strain measurements are displayed as a semitransparent color map called an elastogram, which is overlaid on the b-mode image. Typically, low strain (stiff tissue) is displayed in blue, and high strain (soft tissue) is displayed in red, although the color scale can vary depending on the ultrasound vendor. A pseudo-quantitative measurement called the strain ratio can be used, which is the ratio of strain measured in adjacent (usually normal) reference tissue region of interest (ROI) to strain measured in a target lesion ROI. SR \>1 indicates that the target lesion compresses less than the normal reference tissue, indicating lower strain and greater stiffness.The receiver operating characteristics (ROC) analysis was used to determine whether the mean strain ratio values had a statistically significant effect on the differentiation in well known pathological prognostic factors.

次要结局

未报告次要终点

研究者

发起方
Alper seyhan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alper seyhan

assoc. prof.

Aydin Adnan Menderes University

研究点 (1)

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