Sentinel Lymph Nodes Biopsy in Cervical Cancer

June 13, 2024 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Sentinel Lymph Nodes Biopsy Versus Lymphadenectomy in Cervical Cancer

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Women did not receive surgical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sentinel Lymph Node
Sentinel lymph node biopsy in patients with early stage cervical cancer
Procedure: sentinel lymph node biopsy
sentinel lymph node biopsy
Lymphadenectomy
Comprehensive lymphadenectomy in patients with early stage cervical cancer
Procedure: comprehensive pelvic lymphadenectomy
comprehensive pelvic lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 5 years
progression free survival between these two groups
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
overall survival between these two groups
5 years
Number of dissected lymph node
Time Frame: 5 years
Number of dissected lymph node between these two groups
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 5 years
Compication rates between the traditional and sentinel lymph node dissection groups
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112154-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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