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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05912972
Collaborator
(none)
13,500
Enrollment
1
Location
60
Anticipated Duration (Months)
225
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient registry

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
13500 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Development and Management of Registry in Patients With Gynecologic Cancer in Korea
Actual Study Start Date :
Oct 21, 2022
Anticipated Primary Completion Date :
Oct 21, 2027
Anticipated Study Completion Date :
Oct 21, 2027

Arms and Interventions

Arm Intervention/Treatment
Cervical cancer

No interventions

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

No interventions

Other: Patient registry
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
Ovarian cancer, Fallopian tube cancer, Peritoneal cancer

No interventions

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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [5 years]

    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

Secondary Outcome Measures

  1. Progression-free survival [5 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Seoul Korea, Republic of 138-736

Sponsors and Collaborators

  • Asan Medical Center

Investigators

  • Principal Investigator: Jeong-Yeol Park, PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeong-Yeol Park, MD, PhD, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT05912972
Other Study ID Numbers:
  • 2022-1412
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometrial Neoplasms
Fallopian Tube Neoplasms

Study Results

No Results Posted as of Jun 22, 2023