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NCT06032481 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06032481
Other study ID # FujianMCHH-Xu01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date March 15, 2023

Study information
Verified date September 2023
Source Fujian Maternity and Child Health Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 426
Est. completion date March 15, 2023
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery
Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fujian Maternity and Child Health Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival death or loss of follow-up 60 months
Secondary Risk factors influenced LNM A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM. 60 months
Secondary The accuracy of the model 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
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