Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

Epithelial Ovarian Cancer Clinical Trial

Official title:

Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085456
• Other study ID #: IIT-2023-0202
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: RenJi Hospital
• Contact: Sijia Gu
• Phone: 86+15021845201
• Email: gusijia47[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• Hematologic features
Hematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery

Locations

Country	Name	City	State
China	Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of diagnosed patients	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	one month after surgery
Secondary	Overall survival	The time from the first surgical or biopsy diagnosis of epithelial ovarian cancer to confirmed death or the end of follow-up	up to 5 years
Secondary	Progression-free survival	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	up to 5 years