Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)

February 9, 2021 updated by: Ozguc Takmaz, Acibadem University

Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)

The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.

Study Overview

Detailed Description

Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.

Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

      • Istanbul, Turkey, 34457
        • Recruiting
        • Acibadem MAA University Maslak Hospital
        • Contact:
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with Early stage ovarian cancer

Exclusion Criteria:

  • Patient who had been administrated chemotherapy prior to surgery
  • Patients who had diagnosed with malignancy other than ovarian cancer.
  • Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
  • Patients who have allergy for the tracers.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Sentinel Lymph Node
Sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.
Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sentinel lymph node localization
Time Frame: 12 months
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
12 months
Sentinel lymph node technique accuracy in ovarian cancer
Time Frame: 12 months
Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
12 months
PPV and NPV of sentinel lymph node procedure in ovarian cancer
Time Frame: 12 months
Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
12 months
Adverse events
Time Frame: 12 months
Adverse events related with sentinel lymph node procedure in ovarian cancer
12 months
Sentinel lymph node detection rate
Time Frame: 12 months
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracer comparisons
Time Frame: 12 months
Detection rate differences between different tracers
12 months
Assessment of the sentinel tecniques
Time Frame: 12 months
Evaluation of the tracer injection techniques whether before the excision of the mass or after the excision of the mass for the effectiveness of sentinel lymph node detection.
12 months

Collaborators and Investigators

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

Investigators

  • Study Director: Mete Gungor, Prof., Acibadem MAA University Maslak 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)

January 1, 2021

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (ACTUAL)

January 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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