NCT06085456

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

October 10, 2023

Last Update Submit

October 16, 2023

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial Ovarian CancerDiagnosisPrognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival

    up to 5 years

  • Progression-free survival

    up to 5 years

Study Arms (2)

EOC group

Patients diagnosed with epithelial ovarian cancer

Diagnostic Test: Hematologic features

Control group

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

Diagnostic Test: Hematologic features

Interventions

Hematologic featuresDIAGNOSTIC_TEST

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

Control groupEOC group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialDisease

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aimin Zhao, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sijia Gu

CONTACT

86+15021845201gusijia47@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 17, 2023

Study Start

September 1, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)