Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer|
- Sensitivity/Specificity [ Time Frame: 2014-12-31 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527396
|Korea, Republic of|
|Korean Gynecologic Oncology Group||Recruiting|
|Seoul, Kangnam-gu, Korea, Republic of, 135010|
|Contact: Eunkyung Park +82-2-512-5420 firstname.lastname@example.org|
|Study Chair:||Sokbom Kang||National Cancer Center, Korea|