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

• ClinicalTrials.gov Identifier: NCT03563781
• Recruitment Status: Unknown
• First Posted: June 20, 2018
• Last Update Posted: March 12, 2019
• Sponsor: Catholic University of the Sacred Heart
• Information provided by (Responsible Party): Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Tracking Information

• First Submitted Date: June 10, 2018
• First Posted Date: June 20, 2018
• Last Update Posted Date: March 12, 2019
• Actual Study Start Date: March 1, 2018
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2018)

• 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
• Detection rate [ Time Frame: 24 months ]
  The rate of patients in whom the sentinel node is detected

Original Primary Outcome Measures (submitted: June 19, 2018)

• Feasibility and detection rate [ Time Frame: 24 months ]
  The number of patients in whom the sentinel node procedure is completed, compared to the total number of cases
• Accuracy [ Time Frame: 24 months ]
  The negative predictive value of sentinel node in assessing nodal status The negative predictive value of sentinel node in assessing nodal status The negative predictive value of sentinel node in assessing nodal status

Current Secondary Outcome Measures (submitted: October 25, 2018)

Negative predictive value [ Time Frame: 24 months ]

The negative predictive value of sentinel node in assessing nodal status

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SEntine Lymph Node in earLY Ovarian Cancer (SELLY)
• Official Title: SEntine Lymph Node in earLY Ovarian Cancer
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

All patients with early ovarian cancer will receive sentinel node procedure before full lymphadenectomy, in order to assess the accuracy of sentinel node in diagnosing the presence of nodal metastases.

Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition

• Sentinel Lymph Node
• Ovarian Cancer Stage I

Intervention

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.

Study Arms

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)

Intervention: Procedure: Sentinel node detection

Publications *

• Uccella S, Gisone B, Stevenazzi G, Ghezzi F. Laparoscopic sentinel node detection with ICG for early ovarian cancer: Description of a technique and literature review. Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:193-194. doi: 10.1016/j.ejogrb.2017.12.004. Epub 2017 Dec 6. No abstract available.
• Sadeghi R. Feasibility of Sentinel Node Mapping in Ovarian Tumors: What Is the Evidence? Int J Gynecol Cancer. 2018 Feb;28(2):421-422. doi: 10.1097/IGC.0000000000001158. No abstract available.
• Nyberg RH, Korkola P, Maenpaa JU. Sentinel Node and Ovarian Tumors: A Series of 20 Patients. Int J Gynecol Cancer. 2017 May;27(4):684-689. doi: 10.1097/IGC.0000000000000948.
• Scambia G, Nero C, Uccella S, Vizza E, Ghezzi F, Cosentino F, Chiantera V, Fagotti A. Sentinel-node biopsy in early stage ovarian cancer: a prospective multicentre study (SELLY). Int J Gynecol Cancer. 2019 Nov;29(9):1437-1439. doi: 10.1136/ijgc-2019-000886. Epub 2019 Oct 9.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 3, 2019): 176
• Original Estimated Enrollment (submitted: June 19, 2018): 100
• Estimated Study Completion Date: February 28, 2021
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Evidence of extraovarian disease
• Allergy to the materials used

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This is a gynecologic study therefore only biologically female patients will be included

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT03563781
• Other Study ID Numbers: CICOG-2-3-18/12
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The IPD will be shared only with those making official request to the study investigator
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: The data will become available One year after publication, and they will be available for 6 months.
• Access Criteria: Direct request to the study PI

• Current Responsible Party: Prof. Giovanni Scambia, Catholic University of the Sacred Heart
• Original Responsible Party: Same as current
• Current Study Sponsor: Catholic University of the Sacred Heart
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Catholic University of the Sacred Heart
• Verification Date: March 2019