Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 529
- Locations
- 1
- Primary Endpoint
- Diagnostic odds ratio
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Sokbom Kang
Director, Gynecologic Oncology Research Div.
National Cancer Center, Korea
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
Outcomes
Primary Outcomes
Diagnostic odds ratio
Time Frame: 2014-12-31
Sensitivity/Specificity
Time Frame: 2014-12-31
Negative predictive value
Time Frame: 2014-12-31