Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
Primary Purpose
Ovarian Cancer, Sentinel Lymph Node
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sentinel lymph node detection
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Cancer
Eligibility 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.
Sites / Locations
- Acibadem MAA University Maslak HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sentinel Lymph Node
Arm Description
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.
Outcomes
Primary Outcome Measures
Sentinel lymph node localization
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
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
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.
Adverse events
Adverse events related with sentinel lymph node procedure in ovarian cancer
Sentinel lymph node detection rate
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
Secondary Outcome Measures
Tracer comparisons
Detection rate differences between different tracers
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04714931
Brief Title
Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
Official Title
Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Sentinel Lymph Node
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, Controlled, not randomized
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sentinel Lymph Node
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sentinel lymph node detection
Intervention Description
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 Measure Information:
Title
Sentinel lymph node localization
Description
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
Time Frame
12 months
Title
Sentinel lymph node technique accuracy in ovarian cancer
Description
Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
Time Frame
12 months
Title
PPV and NPV of sentinel lymph node procedure in ovarian cancer
Description
Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
Time Frame
12 months
Title
Adverse events
Description
Adverse events related with sentinel lymph node procedure in ovarian cancer
Time Frame
12 months
Title
Sentinel lymph node detection rate
Description
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Tracer comparisons
Description
Detection rate differences between different tracers
Time Frame
12 months
Title
Assessment of the sentinel tecniques
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozguc Takmaz, Assist.Prof
Phone
+905554006591
Email
ozguctakmaz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mete Gungor, Prof.
Organizational Affiliation
Acibadem MAA University Maslak Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Acibadem MAA University Maslak Hospital
City
Istanbul
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozguc Takmaz, Assist.Prof.
Phone
+905554006591
Email
ozguctakmaz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mete Gungor, Prof.
Phone
+902123044970
Email
mete.gungor@acibadem.com
12. IPD Sharing Statement
Learn more about this trial
Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
We'll reach out to this number within 24 hrs