Efficacy of Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing it to the results obtained from systematic lymphadenectomy, each performed in participants with a suspicious adnexal mass for early-stage ovarian cancer.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Must have a suspicious adnexal mass for early stage ovarian cancer
• Must be medically and surgically fit enough to perform SLNB and complete the systematic lymphadenectomy.
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Locations
Other Locations
Turkey
Istanbul University
RECRUITING
Istanbul
Contact Information
Primary
Mustafa ALBAYRAK, MD
mustafaalbayrak@icloud.com
+90 532 687 10 51
Backup
Yagmur MİNARECİ, MD
yagmurminareci@gmail.com
+90 505 357 43 61
Time Frame
Start Date: 2023-04-15
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 100
Treatments
Experimental: Sentinel Lymph Node Biopsy and Systematic Lymph Node Dissection (Single Arm)
This is a single arm interventional study in which the interventional and control arms are the same participant (each participant becomes its own control since the sentinel node biopsy- interventional arm - results are to be compared to systematic lymphadenectomy results-control arm). Intervention is injection of 2-4 mL sterile charcoal to the infundibulopelvic ligament or mesovarium of the suspicious adnexal mass followed by collection of stained sentinel lymph nodes and lymph nodes by systematic lymphadenectomy.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University