- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04714931
Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ozguc Takmaz, Assist.Prof
- Phone Number: +905554006591
- Email: ozguctakmaz@hotmail.com
Study Locations
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Istanbul, Turkey, 34457
- Recruiting
- Acibadem MAA University Maslak Hospital
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Contact:
- Ozguc Takmaz, Assist.Prof.
- Phone Number: +905554006591
- Email: ozguctakmaz@hotmail.com
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Contact:
- Mete Gungor, Prof.
- Phone Number: +902123044970
- Email: mete.gungor@acibadem.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sentinel lymph node localization
Time Frame: 12 months
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Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
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12 months
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Sentinel lymph node technique accuracy in ovarian cancer
Time Frame: 12 months
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Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
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12 months
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PPV and NPV of sentinel lymph node procedure in ovarian cancer
Time Frame: 12 months
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Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
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12 months
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Adverse events
Time Frame: 12 months
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Adverse events related with sentinel lymph node procedure in ovarian cancer
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12 months
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Sentinel lymph node detection rate
Time Frame: 12 months
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Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tracer comparisons
Time Frame: 12 months
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Detection rate differences between different tracers
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12 months
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Assessment of the sentinel tecniques
Time Frame: 12 months
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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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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mete Gungor, Prof., Acibadem MAA University Maslak Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- TRSGO-SLN-OO5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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