Ovarian NeoplasmsKOBOTNCT02803970
KOrean Borderline Ovarian Tumor (KOBOT) Registry
An observational study of Ovarian Neoplasms, run by Kangbuk Samsung Hospital at 4 sites in South Korea.
Trial summary
The aim of this study is to collect data on Korean patients with borderline ovarian tumors. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms
- How many people
- 3,000 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Dec 1994to Dec 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Korean patients with borderline ovarian tumors (BOTs)
Who may be able to join
- 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
Who cannot join
- Patients who did not receive primary treatment or follow-up for at least 6 months at each institution were excluded from analysis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Samsung Changwon Hospital
Changwon
Min Kyu Kim, MD PhD, 821071919285, seoulminkyukim@gmail.com
Min Kyu Kim, MD, PhD
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Taejong Song, 82-2-2001-2582, taejong.song@gmail.com
Taejong Song, MD, PhD
- Recruiting
CHA Gangnam Medical Center
Seoul, 06135
Seok Ju Seong, MD, PhD, 821089483124, sjseongcheil@naver.com
Seok Ju Seong, MD, PhD
- Recruiting
Samsung Medical Center
Seoul, 06351
Byoung-Gie Kim, MD PhD, 82-2-3410-3513, bgkim@skku.edu
Byoung-Gie Kim, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Neoplasms
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Measured: up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startDec 1994
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD, PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803970
- Sponsor's protocol ID
- 2015-08-002
- Acronym
- KOBOT
- Status last verified
- Apr 2019
- First submitted
- 11 Jun 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Registry of Korean Patients With Borderline Ovarian Tumors
- ClinicalTrials.gov ID
- NCT02803970
- Acronym / sponsor ID
- KOBOT / 2015-08-002
- Conditions
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Dec 1994
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Korean patients with borderline ovarian tumors (BOTs)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who did not receive primary treatment or follow-up for at least 6 months at each institution were excluded from analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence-free survival
Time frame: up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taejong Song, MD, PhD principal investigator
Kangbuk Samsung Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Kangbuk Samsung Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taejong Song, MD,PhD (82-2-2001-2582, taejong.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.