Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

October 16, 2023 updated by: RenJi Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed as primary epithelial ovarian cancer or patients diagnosed as benign gynecological diseases including ovarian cysts, uterine fibroids, and uterine prolapse

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EOC group
Patients diagnosed with epithelial ovarian cancer
Diagnostic test: Hematologic features
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.
Diagnostic test: Hematologic features
Hematologic features including blood routine tests, blood biochemical indicators, and tumor markers before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of diagnosed patients
Time Frame: 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
one month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
up to 5 years
Progression-free survival
Time Frame: 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
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Aimin Zhao, MD, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2023-0202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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