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

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ClinicalTrials.gov Identifier: NCT06032481
Recruitment Status : Completed
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Yebin Feng, Fujian Maternity and Child Health Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Cervical Cancer 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 Design
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Study Type : Observational
Actual Enrollment : 426 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Groups and Cohorts
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Intervention Details:
  • Procedure: surgery
    Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 60 months ]
    death or loss of follow-up


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 426 patients with cervical cancer who underwent radical resection in China were recruited
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06032481


Sponsors and Collaborators
Fujian Maternity and Child Health Hospital
Investigators
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Principal Investigator: Pengming Sun, Ph.D Fujian Maternity and Child Health Hospital
More Information
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Responsible Party: Yebin Feng, Director, Fujian Maternity and Child Health Hospital
ClinicalTrials.gov Identifier: NCT06032481    
Other Study ID Numbers: FujianMCHH-Xu01
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Lymphatic Metastasis
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases