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Completed

NCT Number: NCT01527396

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Korean Gynecologic Oncology Group

Seoul, Kangnam-gu, 135010, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Korean Gynecologic Oncology Group

Registry information

Official study title

Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer

Acronym: PALME

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 7, 2012
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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