Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06085456
Collaborator
(none)
1,000
1
33.9
29.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hematologic features

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Individualized Health Management of Epithelial Ovarian Cancer: A Retrospective Study
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT06085456
Other Study ID Numbers:
  • IIT-2023-0202
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RenJi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023