Development and Management of Registry in Patients With Gynecologic Cancer in Korea

June 12, 2023 updated by: Jeong-Yeol Park, MD, PhD, Asan Medical Center
The goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of Korean gynecologic cancer patients. Ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical cancer, endometrial cancer, and ovarian cancer represent gynecologic cancers. There are many open issues that need to be addressed, specifically the surgical method, disease recurrence and survival outcome in the so called "real world" setting. The aim of this observational study is to collect both retrospective and prospective medical information of gynecologic cancer patients.

Study Type

Observational

Enrollment (Estimated)

13500

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 Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
        • 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 with gynecologic cancer undergoing treatment

Description

Inclusion Criteria:

  • Female patients 18 years or older
  • Written informed consent (prospective cohort)
  • Confirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer

Exclusion Criteria:

  • Unconfirmed diagnosis of cervical cancer, endometrial cancer or 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
Cervical cancer
No interventions
Other: Patient registry
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
Endometrial cancer
No interventions
Other: Patient registry
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
Ovarian cancer, Fallopian tube cancer, Peritoneal cancer
No interventions
Other: Patient registry
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Analyzed for all patients as time from diagnosis to death as a result of any cause, stratified according to baseline characteristics, surgical methods, and treatment
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years
Analyzed for all patients, as time from diagnosis to progression of disease or death as a result of any cause, stratified according to baseline characteristics, surgical methods, and treatment
5 years

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Jeong-Yeol Park, PhD, Asan Medical Center

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)

October 21, 2022

Primary Completion (Estimated)

October 21, 2027

Study Completion (Estimated)

October 21, 2027

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1412

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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