Skip to main content
OpenTrials
Completed

NCT Number: NCT06032481

System to Evaluate the Risk of Lymph Node Metastasis Preoperatively 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–70 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Surgery

Procedure

Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

Primary outcomes

  1. Overall survival

    Time frame: 60 months

    death or loss of follow-up

Secondary outcomes

  1. Risk factors influenced LNM

    Time frame: 60 months

    A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fujian Maternity and Child Health Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.