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

Not Applicable

• Conditions: Ovarian Cancer; Sentinel Lymph Node
• Interventions: Diagnostic Test: Sentinel lymph node detection

• Registration Number: NCT04714931
• Lead Sponsor: Acibadem University

Brief Summary

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

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 Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node	Sentinel lymph node detection	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tracer comparisons	12 months	Detection rate differences between different tracers
Assessment of the sentinel tecniques	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.

Trial Locations

Locations (1)

Acibadem MAA University Maslak Hospital; 🇹🇷 Istanbul, Turkey