SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

Not Applicable

Completed

• Conditions: Sentinel Lymph Node; Ovarian Cancer Stage I
• Interventions: Procedure: Sentinel node detection

• Registration Number: NCT03563781
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-11-11
• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Primary Completion: 2022-07-29
• Study Completion: 2023-05-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

• Epithelial ovarian cancer
• Early stage disease limited to the ovary

Exclusion Criteria

• Evidence of extraovarian disease
• Allergy to the materials used

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SENTINEL NODE	Sentinel node detection	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)

Primary Outcome Measures

Name	Time	Method
Detection rate	24 months	The rate of patients in whom the sentinel node is detected
Number of participants with procedure-related adverse events	6 months	The number of patients with procedure-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Negative predictive value	24 months	The negative predictive value of sentinel node in assessing nodal status

Trial Locations

Locations (1)

Giovannni Scambia; 🇮🇹 Rome, Italy