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Sentinel Lymph Node Biopsy in Patients With Early Stages Cervical Cancer

NCT02494063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-02-08

No results posted yet for this study

Summary

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.

The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after systematic pelvic lymphadenectomy, but that the less radical surgery is associated with significantly lower postoperative morbidity.

Conditions

Interventions

PROCEDURE

Sentinel lymph node biopsy

Bilateral sentinel lymph node biopsy, pathologic ultrastaging

PROCEDURE

At least unilateral systematic pelvic lymph node dissection

Sponsors & Collaborators

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • David Cibula, MD · Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital and 1st Faculty of Medicine, Charles University Prague, Czechia

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2022-12-31
Completion
2024-02-29

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494063 on ClinicalTrials.gov