Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

NCT ID: NCT06085456

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Epithelial Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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EOC group

Patients diagnosed with epithelial ovarian cancer

Hematologic features

Intervention Type DIAGNOSTIC_TEST

Hematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery

Control group

Patients diagnosed with benign gynecological diseases, including ovarian cysts, uterine fibroids and uterine prolapse.

Hematologic features

Intervention Type DIAGNOSTIC_TEST

Hematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery

Interventions

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Hematologic features

Hematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimin Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sijia Gu

Role: CONTACT

86+15021845201

Facility Contacts

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Sijia Gu

Role: primary

86+15021845201

Other Identifiers

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IIT-2023-0202

Identifier Type: -

Identifier Source: org_study_id

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