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

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

Detailed Description
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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.

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

Conditions
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Ovarian Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Diagnostic Test: Sentinel lymph node detection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, Controlled, not randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sentinel Lymph Node<br>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. | Diagnostic Test: Sentinel lymph node detection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel lymph node localization | 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 | 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 | Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer. | 12 months | 
| Adverse events | Adverse events related with sentinel lymph node procedure in ovarian cancer | 12 months | 
| Sentinel lymph node detection rate | 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 | Detection rate differences between different tracers | 12 months | 
| Assessment of the sentinel tecniques | 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 |