NCT06032481

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7.9 years

First QC Date

August 26, 2023

Last Update Submit

September 4, 2023

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    death or loss of follow-up

    60 months

Secondary Outcomes (2)

  • Risk factors influenced LNM

    60 months

  • The accuracy of the model

    60 months

Interventions

surgeryPROCEDURE

Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 426 patients with cervical cancer who underwent radical resection in China were recruited

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Pengming Sun, Ph.D

    Fujian Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 13, 2023

Study Start

January 1, 2012

Primary Completion

December 1, 2019

Study Completion

March 15, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09