KOrean Borderline Ovarian Tumor (KOBOT) Registry (KOBOT)

April 1, 2019 updated by: Taejong Song, Kangbuk Samsung Hospital

Establishing the Registry of Korean Patients With Borderline Ovarian Tumors

The aim of this study is to collect data on Korean patients with borderline ovarian tumors.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The researchers retrospectively collected data on Korean patients with borderline ovarian tumors (BOTs) diagnosed, treated, and followed between November 1994 and February 2015 at institutions where placed in the Republic of Korea. And the researchers prospectively will collect data on all Korean patients with BOTs at institutions where placed in the Republic of Korea since March, 2015. If patients agree to participate in this KOBOT registry, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

Study Type

Observational

Enrollment (Anticipated)

3000

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

  • Korea, Republic of
      • Changwon, Korea, Republic of
        • Recruiting
        • Samsung Changwon Hospital
        • Contact:
        • Principal Investigator:
          • Min Kyu Kim, MD, PhD
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Byoung-Gie Kim, MD PhD
          • Phone Number: 82-2-3410-3513
          • Email: bgkim@skku.edu
        • Principal Investigator:
          • Byoung-Gie Kim, MD, PhD
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
      • Seoul, Korea, Republic of, 06135
        • Recruiting
        • CHA Gangnam Medical Center
        • Contact:
        • Principal Investigator:
          • Seok Ju Seong, MD, PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Korean patients with borderline ovarian tumors (BOTs)

Description

Inclusion Criteria:

  • Patients with borderline ovarian tumors (BOTs) diagnosed, treated, and followed between November 1994 and February 2015 at institutions where placed in the Republic of Korea.
  • All patients undergoing gynecologic surgery for BOTs at institutions where placed in the Republic of Korea since March, 2015

Exclusion Criteria:

  • Patients who did not receive primary treatment or follow-up for at least 6 months at each institution were excluded from analysis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival
Time Frame: up to 100 months
up to 100 months

Collaborators and Investigators

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

Sponsor

Kangbuk Samsung Hospital

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

December 1, 1994

Primary Completion (Anticipated)

December 1, 2040

Study Completion (Anticipated)

December 1, 2040

Study Registration Dates

First Submitted

June 11, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-08-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Ovarian Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe