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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714931
• Other study ID #: TRSGO-SLN-OO5
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2021
• Source: Acibadem University
• Contact: Ozguc Takmaz, Assist.Prof
• Phone: +905554006591
• Email: ozguctakmaz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
Turkey	Acibadem MAA University Maslak Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel lymph node localization	Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.	12 months
Primary	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
Primary	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
Primary	Adverse events	Adverse events related with sentinel lymph node procedure in ovarian cancer	12 months
Primary	Sentinel lymph node detection rate	Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.	12 months
Secondary	Tracer comparisons	Detection rate differences between different tracers	12 months
Secondary	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