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

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

Study Description
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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.
Study Design
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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
Groups and Cohorts
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Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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
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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
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Study Chair: Sokbom Kang National Cancer Center, Korea
More Information
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Responsible Party: Sokbom Kang, Director, Gynecologic Oncology Research Div., National Cancer Center, Korea
ClinicalTrials.gov 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
lymphadenectomy
risk criteria
Additional relevant MeSH terms:
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Neoplasm Metastasis
Endometrial Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases