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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06032481

Enrollment

426

Registered

2023-09-13

Start date

2012-01-01

Completion date

2023-03-15

Last updated

2023-09-13

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

Conditions

Cervical Cancer

Brief summary

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.

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.

Interventions

PROCEDUREsurgery

Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	60 months	death or loss of follow-up

Secondary

Measure	Time frame	Description
Risk factors influenced LNM	60 months	A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.
The accuracy of the model	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026