Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
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|ClinicalTrials.gov Identifier: NCT04714931|
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Sentinel Lymph Node||Diagnostic Test: Sentinel lymph node detection||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, Controlled, not randomized|
|Masking:||None (Open Label)|
|Official Title:||Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)|
|Actual Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
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.
Diagnostic Test: Sentinel lymph node detection
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.
- Sentinel lymph node localization [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
- Adverse events [ Time Frame: 12 months ]Adverse events related with sentinel lymph node procedure in ovarian cancer
- Sentinel lymph node detection rate [ Time Frame: 12 months ]Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
- Tracer comparisons [ Time Frame: 12 months ]Detection rate differences between different tracers
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714931
|Contact: Ozguc Takmaz, Assist.Profemail@example.com|
|Study Director:||Mete Gungor, Prof.||Acibadem MAA University Maslak Hospital|