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NCT05912972 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
Development and Management of Registry in Patients With Gynecologic Cancer in Korea

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05912972
Other study ID # 2022-1412
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 21, 2022
Est. completion date October 21, 2027

Study information
Verified date June 2023
Source Asan Medical Center
Contact Jeong-Yeol Park, PhD
Phone +82230103646
Email obgyjypark@amc.seoul.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 13500
Est. completion date October 21, 2027
Est. primary completion date October 21, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Patient registry
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures

Locations
Country Name City State
Korea, Republic of Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 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 Progression-free survival 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
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