KOrean Borderline Ovarian Tumor (KOBOT) Registry

Ovarian Neoplasms Clinical Trial

— KOBOT  

Official title:

Establishing the Registry of Korean Patients With Borderline Ovarian Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02803970
• Other study ID #: 2015-08-002
• Status: Recruiting
• Start date: December 1994
• Est. completion date: December 2040

Study information

• Verified date: April 2019
• Source: Kangbuk Samsung Hospital
• Contact: Taejong Song, MD,PhD
• Phone: 82-2-2001-2582
• Email: taejong.song[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Samsung Changwon Hospital	Changwon
Korea, Republic of	CHA Gangnam Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival		up to 100 months