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Recruiting NCT02803970

KOrean Borderline Ovarian Tumor (KOBOT) Registry

Observational Ovarian Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ovarian Neoplasms. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Establishing the Registry of Korean Patients With Borderline Ovarian Tumors

Overview

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

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.

Primary outcome measures

  • Recurrence-free survival [Time frame: up to 100 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 4 centers
  • Samsung Changwon Hospital — Changwon
  • Kangbuk Samsung Hospital — Seoul
  • CHA Gangnam Medical Center — Seoul
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT02803970 · 2015-08-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗