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临床试验/NCT06085456
NCT06085456招募中不适用

Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年9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
1,000
试验地点
1
主要终点
Number of diagnosed patients

研究概览

简要总结

The purpose of this study is to identify the demographic and sociological characteristics of epithelial ovarian cancer in a cohort, identify the risk factors of epithelial ovarian cancer, effectively identify the high-risk population of epithelial ovarian cancer in the population, implement standardized health management, and clarify the effect of standardized health management on the incidence and prognosis of epithelial ovarian cancer. It can also provide a case control population for the clinical cohort of epithelial ovarian cancer to benefit the majority of postoperative patients.

详细描述

  1. The clinical characteristics, preoperative hematological parameters of patients with epithelial ovarian cancer and patients with benign gynecological diseases, and the pathological stage, grade and features extracted by PET/CT images of patients with epithelial ovarian cancer were recorded.
  2. Patients from Renji Hospital were divided into training group and test group at a ratio of 7:3, and patients from Shanghai First Maternity and Infant Hospital were used as external validation group.
  3. The training group was used to establish the diagnosis and prognosis prediction model of epithelial ovarian cancer, and the test group and the external validation group were used to verify the model, and the area under the ROC curve, accuracy, specificity, and sensitivity were used to evaluate the effect of the model.
  4. For machine learning models, SHAP and LIME algorithms were used for model interpretation.
  5. Unsupervised clustering algorithm was used to distinguish the subgroups of epithelial ovarian cancer patients, and KM was used to analyze the overall survival (OS) and progression-free survival (PFS) to predict the survival and recurrence of the subgroups. Overall survival (OS) was defined as the time from the first diagnosis of epithelial ovarian cancer to the confirmation of death or the end of follow-up. Progression-free survival (PFS) was defined as the time from the first diagnosis of epithelial ovarian cancer to the confirmation of disease progression or the end of follow-up.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients were diagnosed as primary epithelial ovarian cancer with definite pathological stage and grade and underwent preoperative PET/CT examination, or patients diagnosed as benign gynecological diseases including ovarian cysts, uterine fibroids, and uterine prolapse.
  • age between 18 to 80 years old;
  • complete preoperative blood routine test results, blood biochemical indicators, and tumor markers;

排除标准

  • complicated with acute or chronic genital tract infectious diseases;
  • patients with diagnosed tumors other than ovarian cancer;
  • complicated with severe systemic diseases;
  • pregnant or lactating women;
  • patients diagnosed with recurrent epithelial ovarian cancer.

结局指标

主要结局

Number of diagnosed patients

时间窗: one month after surgery

Patients were diagnosed with epithelial ovarian cancer or benign gynecological diseases (including ovarian cysts, uterine fibroids, and uterine prolapse). The blood characteristics of patients with epithelial ovarian cancer and patients with benign gynecological diseases (including ovarian cysts, uterine fibroids, and uterine prolapse) were compared to observe the performance of the study model in predicting disease diagnosis

次要结局

  • Overall survival(up to 5 years)
  • Progression-free survival(up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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