SEntine Lymph Node in earLY Ovarian Cancer (SELLY) (SELLY)

June 20, 2023 updated by: SCAMBIA GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

SEntine Lymph Node in earLY Ovarian Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Giovannni Scambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Evidence of extraovarian disease
  • Allergy to the materials used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SENTINEL NODE
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value
Time Frame: 24 months
The negative predictive value of sentinel node in assessing nodal status
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Giovanni Scambia, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2017

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

June 10, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICOG-2-3-18/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be shared only with those making official request to the study investigator

IPD Sharing Time Frame

The data will become available One year after publication, and they will be available for 6 months.

IPD Sharing Access Criteria

Direct request to the study PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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