Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorIstanbul University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Sentinel lymph node biopsy (using sterile charcoal stain) in early ovarian cancer
Diagnostic testDescribed in previous sections
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Sentinel Lymph Node Biopsy and Systematic Lymph Node Dissection (Single Arm)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of sentinel lymph node biopsy in highly suspicious adnexal masses for early-stage ovarian cancer
Sensitivity, specificity, positive and negative predictive value for sentinel lymph biopsy results (compared to lymph nodes collected by systemic lenfadenopathy) will be calculated. These calculations will be expressed in percentages and will be compared using appropriate statistical method.
Time frame
From the day of surgery to final pathology report (two weeks)Sponsors and contacts
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Source ClinicalTrials.gov