Brief Title
Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer
Official Title
Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer
Brief Summary
The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node
metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial
cancer.
Detailed Description
The Korean Gynecologic Oncology Group (KGOG) undertook a multi-center retrospective study to
develop a preoperative prediction model for lymph node metastasis in endometrial cancer
(KGOG-2014). This retrospective multi-center study showed that the accurate identification of
a low-risk group for lymph node metastasis among the patients with endometrial cancer can be
achieved with the new criteria using preoperative MRI and serum CA-125 assay. In this study,
serum CA125 levels and three MRI parameters (deep myometrial invasion, lymph node
enlargement, and extension beyond uterine corpus) were found to be independent risk factors
for nodal metastasis. Based on the success of KGOG-2014, Korean Gynecologic Oncology Group
initiated this prospective, multi-center observational study to validate our prior prediction
model.
Study Type
Observational
Primary Outcome
Sensitivity/Specificity
Condition
Endometrial Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
529
Start Date
December 2011
Completion Date
August 2015
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
- Patients with a histologic diagnosis of endometrial cancer before surgical staging.
- Patients with a preoperative magnetic resonance imaging (MRI) and serum CA-125 within
4 weeks from surgical staging.
- Patients who underwent adequate systemic lymph node dissection during surgical
staging.
Exclusion Criteria:
- Patients with a histologic feature suggesting sarcoma or squamous cell carcinoma
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Sokbom Kang, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01527396
Organization ID
KGOG2015
Responsible Party
Principal Investigator
Study Sponsor
National Cancer Center, Korea
Collaborators
Korean Gynecologic Oncology Group
Study Sponsor
Sokbom Kang, Study Chair, National Cancer Center, Korea
Verification Date
October 2015