Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by National Cancer Center, Korea.
Recruitment status was Recruiting
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea
First received: February 2, 2012
Last updated: February 6, 2012
Last verified: February 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer
| Estimated Enrollment:
| Study Start Date:
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Endometrial cancer patients who undergo surgery including systemic lymph node dissection
- 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.
- Patients with a histologic feature suggesting sarcoma or squamous cell carcinoma
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01527396
|Korean Gynecologic Oncology Group
|Seoul, Kangnam-gu, Korea, Republic of, 135010 |
|Contact: Eunkyung Park +82-2-512-5420 email@example.com |
National Cancer Center, Korea
Korean Gynecologic Oncology Group
||National Cancer Center, Korea
No publications provided
||Sokbom Kang, Director, Gynecologic Oncology Research Div., National Cancer Center, Korea
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 2, 2012
||February 6, 2012
||Korea: Food and Drug Administration
Keywords provided by National Cancer Center, Korea:
lymph node metastasis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Genital Neoplasms, Female
Neoplasms by Site
Genital Diseases, Female