System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer

September 4, 2023 updated by: Yebin Feng, Fujian Maternity and Child Health Hospital

Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer

The lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation.

Study Overview

Status

Completed

Conditions

Cervical Cancer

Intervention / Treatment

Procedure: surgery

Detailed Description

Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or computed tomography (CT) tests are less sensitive to assess the risk of lymph node metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.

Study Type

Observational

Enrollment (Actual)

426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

A total of 426 patients with cervical cancer who underwent radical resection in China were recruited

Description

Inclusion Criteria:

Clinical diagnosis of cervical cancer
FIGO stage IB1-IIA1
Undergone radical hysterectomy with pelvic lymphadenectomy
Peformed pelvic MRI examination preoperatively

Exclusion Criteria:

Had distant metastases diagnosed before or during the surgery
Underwent neoadjuvant radiotherapy preoperatively
Underwent neoadjuvant chemotherapy preoperatively
Incomplete or inaccuratemedical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: 60 months	death or loss of follow-up	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors influenced LNM Time Frame: 60 months	A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.	60 months
The accuracy of the model Time Frame: 60 months	The AUC curve was used to assess the discrimination of the scoring system. The comparison between predicted (mean ± SD) and observed rates of LNM was used to test the calibration. The Hosmer-Lemeshow test evaluated the model fit.	60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Maternity and Child Health Hospital

Investigators

Principal Investigator: Pengming Sun, Ph.D, Fujian Maternity and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

August 26, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)