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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01527396

Acronym

PALME

Enrollment

529

Registered

2012-02-07

Start date

2011-12-31

Completion date

2015-08-31

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

endometrial cancer, lymph node metastasis, lymphadenectomy, risk criteria

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sensitivity/Specificity	2014-12-31
Negative predictive value	2014-12-31
Diagnostic odds ratio	2014-12-31

Countries

South Korea

Outcome results