An interventional study of Sentinel node detection in Sentinel Lymph Node and Ovarian Cancer Stage I, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients
Patients with early stage ovarian cancer have a good prognosis. However, nearly 15% of the initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate surgical staging due to lymphatic metastasis, despite of preoperative radiological data. Therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a crucial procedure. On the other hand, nodal dissection may be associated with threatening intra- and post-operative complications.
If feasible and accurate, the sentinel lymph node procedure could be a modality to avoid unnecessary radical lymphadenectomy without missing important information on nodal status.
With the present study we aim at exploring the role of sentinel node dissection in early ovarian cancer patients.
Patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will receive injection of a tracer (patent blue or indocyanine green) which have already been proven safe and extremely effective in several other gynecologic and non-gynecologic malignancies. Then the retroperitoneal spaces will be opened as for a standard lymphadenectomy procedure and the lymph node marked with the tracer will be identified. After dissection of the sentinel node, lymphadenectomy will be completed according to current guidelines.
Operative data, pathological findings and accuracy of sentinel node in predicting nodal status will be registered.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 176 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with ovarian cancer will receive sentinel node identification and they will be then submitted to complete pelvic and para-aortic lymphadenectomy (as per the present guidelines)
Procedure: Sentinel node detection
Patients will receive injection of tracer in the ovarian ligaments to identify the lymphatic drainage of the affected ovary and ultimately the sentinel node. Afterwards, systematic lymphadenectomy will be accomplished according to current guidelines.
Number of participants with procedure-related adverse events
The number of patients with procedure-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Detection rate
The rate of patients in whom the sentinel node is detected
Time frame: 24 months
Negative predictive value
The negative predictive value of sentinel node in assessing nodal status
Time frame: 24 months
Plan to share: Yes — The IPD will be shared only with those making official request to the study investigator
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS