System to Evaluate the Risk of Lymph Node Metastasis Preo... | NCT06032481

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

NCT06032481

Sponsor

Fujian Maternity and Child Health Hospital

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

426Actual

Phase

Not provided

Conditions

Cervical Cancer

Interventions

surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Mar 15, 2023Actual

First Submitted Date

Aug 26, 2023

First Submission Date that Met QC Criteria

Sep 4, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2023

Last Update Posted Date

Sep 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yebin Feng, Director, Fujian Maternity and Child Health HospitalPrincipal Investigator

Lead Sponsor

Fujian Maternity and Child Health HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

426Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Risk factors influenced LNM	A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.	60 months
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pengming Sun, Ph.D	Fujian Maternity and Child Health Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided