Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT01527396
• Lead Sponsor: National Cancer Center, Korea

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Primary Completion: 2014-12
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 529

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity/Specificity	2014-12-31
Negative predictive value	2014-12-31
Diagnostic odds ratio	2014-12-31

Trial Locations

Locations (1)

Korean Gynecologic Oncology Group; 🇰🇷 Seoul, Kangnam-gu, Korea, Republic of