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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527396
First Posted: February 7, 2012
Last Update Posted: October 28, 2015
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.
Collaborator:
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea
  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

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

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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
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 ClinicalTrials.gov identifier (NCT number): NCT01527396


Locations
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
Investigators
Study Chair: Sokbom Kang National Cancer Center, Korea
  More Information

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
First Submitted: February 2, 2012
First Posted: February 7, 2012
Last Update Posted: October 28, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Endometrial Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female