Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Endometrial Cancer |
| Study Type: | Observational |
| 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 |
| Estimated Enrollment: | 514 |
| Study Start Date: | December 2011 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Endometrial cancer patients who undergo surgery including systemic lymph node dissection
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
Contacts and Locations| Korea, Republic of | |
| Korean Gynecologic Oncology Group | Recruiting |
| Seoul, Kangnam-gu, Korea, Republic of, 135010 | |
| Contact: Eunkyung Park +82-2-512-5420 koreagynonco@hanmail.net | |
| Study Chair: | Sokbom Kang | National Cancer Center, Korea |
More Information
No publications provided
| Responsible Party: | Sokbom Kang, Director, Gynecologic Oncology Research Div., National Cancer Center, Korea |
| ClinicalTrials.gov Identifier: | NCT01527396 History of Changes |
| Other Study ID Numbers: | KGOG2015 |
| Study First Received: | February 2, 2012 |
| Last Updated: | February 6, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by National Cancer Center, Korea:
|
endometrial cancer lymph node metastasis lymphadenectomy risk criteria |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Neoplasm Metastasis Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplastic Processes Pathologic Processes Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013