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NCT06169787 Clinical Trial

Sentinel Lymph Nodes Biopsy in Cervical Cancer

Sentinel Lymph Node Clinical Trial

Official title:
Sentinel Lymph Nodes Biopsy Versus Lymphadenectomy in Cervical Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06169787
Other study ID # 112154-E
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 14, 2023
Est. completion date September 30, 2024

Study information
Verified date April 2024
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date September 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria: Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer Exclusion Criteria: Women did not receive surgical treatment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• sentinel lymph node biopsy
sentinel lymph node biopsy
• comprehensive pelvic lymphadenectomy
comprehensive pelvic lymphadenectomy

Locations
Country Name City State
Taiwan Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other Complications Compication rates between the traditional and sentinel lymph node dissection groups 5 years
Primary progression free survival progression free survival between these two groups 5 years
Secondary overall survival overall survival between these two groups 5 years
Secondary Number of dissected lymph node Number of dissected lymph node between these two groups 5 years
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