Evaluating sentinel lymph node biopsy for early-stage ovarian cancer
Efficacy of Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer
This study is testing if a new type of lymph node surgery can help women with early-stage ovarian cancer get better treatment while reducing the risks of more extensive surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Turkey) |
| Trial ID | NCT05927818 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to assess the efficacy of sentinel lymph node biopsy (SLNB) in patients with early-stage ovarian cancer by comparing its results to those obtained from systematic lymphadenectomy. Ovarian cancer is a leading cause of gynecologic cancer mortality, and accurate staging is crucial for treatment and prognosis. The study focuses on patients with suspicious adnexal masses, as up to 30% may be upstaged based on final pathology. By potentially reducing the need for extensive lymphadenectomy, the SLNB could minimize associated surgical risks.
Who should consider this trial
Good fit: Ideal candidates are women with a suspicious adnexal mass who are medically and surgically fit for the procedures.
Not a fit: Patients with low probability ovarian masses, advanced-stage cancer, or recurrent ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer surgical options for patients with early-stage ovarian cancer.
How similar studies have performed: While SLNB has been successfully integrated into the management of other gynecologic cancers, its application in ovarian cancer is still in the early stages and lacks extensive prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. \- Exclusion Criteria: Ovarian mass with low probability for early stage ovarian cancer. Medical or surgical contraindications for surgical comprehensive staging. Metastatic cancers or double primary cancers (metachronous) of ovary Recurrent ovarian cancer Preoperative or intraoperative finding of advanced ovarian cancer (FİGO stage III and IV) Neoadjuvant ovarian cancer \-
Where this trial is running
Istanbul, Turkey
- Istanbul University — Istanbul, Turkey, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mustafa ALBAYRAK, MD
- Email: mustafaalbayrak@icloud.com
- Phone: +90 532 687 10 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.