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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
Sponsor:
Information provided by (Responsible Party):
Ozguc Takmaz, Acibadem University

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Sentinel Lymph Node Diagnostic Test: Sentinel lymph node detection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Controlled, not randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Sentinel lymph node localization [ Time Frame: 12 months ]
    Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.

  2. 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

  3. 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.

  4. Adverse events [ Time Frame: 12 months ]
    Adverse events related with sentinel lymph node procedure in ovarian cancer

  5. Sentinel lymph node detection rate [ Time Frame: 12 months ]
    Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.


Secondary Outcome Measures :
  1. Tracer comparisons [ Time Frame: 12 months ]
    Detection rate differences between different tracers

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ozguc Takmaz, Assist.Prof +905554006591 ozguctakmaz@hotmail.com

Locations
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Turkey
Acibadem MAA University Maslak Hospital Recruiting
Istanbul, Turkey, 34457
Contact: Ozguc Takmaz, Assist.Prof.    +905554006591    ozguctakmaz@hotmail.com   
Contact: Mete Gungor, Prof.    +902123044970    mete.gungor@acibadem.com   
Sponsors and Collaborators
Acibadem University
Investigators
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Study Director: Mete Gungor, Prof. Acibadem MAA University Maslak Hospital
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Responsible Party: Ozguc Takmaz, MD,Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier: NCT04714931    
Other Study ID Numbers: TRSGO-SLN-OO5
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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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
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type