NCT06169787

Brief Summary

This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

October 14, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 17, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

October 14, 2023

Last Update Submit

June 13, 2024

Conditions

Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    progression free survival between these two groups

    5 years

Secondary Outcomes (2)

  • overall survival

    5 years

  • Number of dissected lymph node

    5 years

Other Outcomes (1)

  • Complications

    5 years

Study Arms (2)

Sentinel Lymph Node

Sentinel lymph node biopsy in patients with early stage cervical cancer

Procedure: sentinel lymph node biopsy

Lymphadenectomy

Comprehensive lymphadenectomy in patients with early stage cervical cancer

Procedure: comprehensive pelvic lymphadenectomy

Interventions

sentinel lymph node biopsyPROCEDURE

sentinel lymph node biopsy

Sentinel Lymph Node
comprehensive pelvic lymphadenectomyPROCEDURE

comprehensive pelvic lymphadenectomy

Lymphadenectomy

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with early stage cervical cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 20 and above with early stage cervical cancer, who received surgical treatment

You may qualify if:

  • Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer

You may not qualify if:

  • Women did not receive surgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 14, 2023

First Posted

December 14, 2023

Study Start

October 14, 2023

Primary Completion

August 31, 2024

Study Completion

September 30, 2024

Last Updated

June 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)