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

This study has been completed.
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea Identifier:
First received: February 2, 2012
Last updated: October 27, 2015
Last verified: October 2015
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.

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 ]
  • Negative predictive value [ Time Frame: 2014-12-31 ] [ Designated as safety issue: No ]
  • Diagnostic odds ratio [ Time Frame: 2014-12-31 ] [ Designated as safety issue: No ]

Enrollment: 529
Study Start Date: December 2011
Study Completion Date: August 2015
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.

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

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
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Please refer to this study by its identifier: NCT01527396

Korea, Republic of
Korean Gynecologic Oncology Group
Seoul, Kangnam-gu, Korea, Republic of, 135010
Sponsors and Collaborators
National Cancer Center, Korea
Korean Gynecologic Oncology Group
Study Chair: Sokbom Kang National Cancer Center, Korea
  More Information

Responsible Party: Sokbom Kang, Director, Gynecologic Oncology Research Div., National Cancer Center, Korea Identifier: NCT01527396     History of Changes
Other Study ID Numbers: KGOG2015 
Study First Received: February 2, 2012
Last Updated: October 27, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
endometrial cancer
lymph node metastasis
risk criteria

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms processed this record on May 23, 2016