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

Endometrial Cancer Clinical Trial

— PALME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527396
• Other study ID #: KGOG2015
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: October 27, 2015
• Start date: December 2011
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Korean Gynecologic Oncology Group	Seoul	Kangnam-gu

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Korean Gynecologic Oncology Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity/Specificity		2014-12-31	No
Primary	Negative predictive value		2014-12-31	No
Primary	Diagnostic odds ratio		2014-12-31	No