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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Cancer Center, Korea
Sponsor:
Collaborator:
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01527396
First received: February 2, 2012
Last updated: October 2, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Sensitivity/Specificity [ Time Frame: 2014-12-31 ] [ Designated as safety issue: No ]

Estimated Enrollment: 514
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)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Endometrial cancer patients who undergo surgery including systemic lymph node dissection

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527396

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   
Sponsors and Collaborators
National Cancer Center, Korea
Korean Gynecologic Oncology Group
Investigators
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: October 2, 2014
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
Neoplasm Metastasis
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014