Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

Recruiting

• Conditions: Epithelial Ovarian Cancer
• Interventions: Diagnostic Test: Hematologic features

• Registration Number: NCT06085456
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• 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;

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Hematologic features	Patients diagnosed with benign gynecological diseases, including ovarian cysts, uterine fibroids and uterine prolapse.
EOC group	Hematologic features	Patients diagnosed with epithelial ovarian cancer

Primary Outcome Measures

Name	Time	Method
Number of diagnosed patients	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

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 5 years	The time from the first surgical or biopsy diagnosis of epithelial ovarian cancer to confirmed death or the end of follow-up
Progression-free survival	up to 5 years	The time from the first surgical or needle biopsy diagnosis of epithelial ovarian cancer to the confirmation of disease progression or the end of follow-up

Trial Locations

Locations (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China