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CompletedNCT06032481Updated Sep 13, 2023

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

An observational study in Cervical Cancer, sponsored by Fujian Maternity and Child Health Hospital. Completed. Open to female participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Fujian Maternity and Child Health Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
426
Ages
25 Years to 70 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 426 is above the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fujian Maternity and Child Health Hospital is the lead sponsor of 14 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
426 participants (actual)
Patient registry
No

Interventions

  • Proceduresurgery

    Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

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What researchers measure

Primary outcomes

  1. Overall survival

    death or loss of follow-up

    Time frame: 60 months

Secondary outcomes

  1. Risk factors influenced LNM

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

    Time frame: 60 months

  2. 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.

    Time frame: 60 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06032481
Lead sponsor
Fujian Maternity and Child Health Hospital
Responsible party
Yebin Feng (Director, Fujian Maternity and Child Health Hospital) — Principal investigator
First posted
Sep 13, 2023
Start date
Jan 1, 2012
Primary completion
Dec 1, 2019
Completion
Mar 15, 2023
Last update
Sep 13, 2023

Study contacts

Pengming Sun, Ph.D
principal investigator · Fujian Maternity and Child Health Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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