Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527396
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : October 28, 2015
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea

Brief Summary:
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 or disease
Endometrial Cancer

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 529 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Primary Outcome Measures :
  1. Sensitivity/Specificity [ Time Frame: 2014-12-31 ]
  2. Negative predictive value [ Time Frame: 2014-12-31 ]
  3. Diagnostic odds ratio [ Time Frame: 2014-12-31 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527396

Layout table for location information
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
Layout table for investigator information
Study Chair: Sokbom Kang National Cancer Center, Korea
Layout table for additonal information
Responsible Party: Sokbom Kang, Director, Gynecologic Oncology Research Div., National Cancer Center, Korea Identifier: NCT01527396    
Other Study ID Numbers: KGOG2015
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Sokbom Kang, National Cancer Center, Korea:
endometrial cancer
lymph node metastasis
risk criteria
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Endometrial Neoplasms
Neoplastic Processes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases