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临床试验/NCT05783986
NCT05783986尚未招募不适用

Developing a MRI-based Deep Learning Model to Predict MMR Status of Endometrial Carcinoma

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 个研究点目标入组 600 人开始时间: 2023年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
主要终点
Area under receiver operating characteristic curve (AUROC)

研究概览

简要总结

In order to develop a convenient, cheap and comprehensive method to preoperatively predict dMMR and reduce the number of people requiring dMMR-related immunohistochemical or genetic testing after surgery, this study aims to establish a deep learning model based on MRI to predict the MMR status of endometrial cancer. Patients diagnosed with endometrial cancer after surgery and who had completed pelvic MRI before surgery were collected. Deep learning was used to combine the clinical model with MR Image data to build the model. ROC curves were constructed for the testing group, internal verification group and external verification group, and the area under ROC curves were calculated to evaluate the diagnostic effect and stability of the model.

The dual threshold triage strategy was used to screen out the pMMR population (below the lower threshold), dMMR population (above the upper threshold) and the uncertain part of the population (between the thresholds).

详细描述

In this study, patients diagnosed with endometrial cancer after surgery and who had completed pelvic MRI before surgery were collected from 2017 to 2022. It is expected to collect 500 cases in our hospital, which are divided into 375 cases (experimental group) and 125 cases (internal verification group).

100 cases of Sun Yat-sen University Cancer Center for external verification. Clinical data (age, gender, BMI, CA125, CA19-9, MR-T staging, immunohistochemical results of MMR-related proteins) of the study population were collected and logistics regression analysis was conducted to establish clinical models. Extract, segment, integrate and enhance MR Image data.

Deep learning was used to combine the clinical model with MR Image data to build the model. ROC curves were constructed for the testing group, internal verification group and external verification group, and the area under ROC curves were calculated to evaluate the diagnostic effect and stability of the model.

The dual threshold triage strategy was used to screen out the pMMR population (below the lower threshold), dMMR population (above the upper threshold) and the uncertain part of the population (between the thresholds). If the predictive score is above the lower threshold, the patient is advised to undergo further immunohistochemical or genetic testing to confirm MMR status or dMMR type

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients diagnosed with endometrial cancer after surgery and who had completed pelvic MRI before surgery from 2017 to 2022

排除标准

  • (1) There was no immunohistochemical detection result of MMR-related protein; (2) Radiotherapy and chemotherapy before MRI; (3) small tumors that are difficult to identify on the image (<5mm) ; (4) The T2-weighted imaging quality is insufficient to plot ROI, such as obvious motion artifacts; (5) There are other gynecological malignancies

结局指标

主要结局

Area under receiver operating characteristic curve (AUROC)

时间窗: one year

The area under receiver operating characteristic curve (AUROC) was used to evaluate the performance of the models

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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