NCT03563781

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4.7 years

First QC Date

June 10, 2018

Last Update Submit

June 20, 2023

Conditions

Sentinel Lymph NodeOvarian Cancer Stage I

Keywords

ovarian cancerlaparoscopysentinel nodelymphadenectomy

Outcome Measures

Primary Outcomes (2)

  • Number of participants with procedure-related adverse events

    The number of patients with procedure-related adverse events as assessed by CTCAE v4.0

    6 months

  • Detection rate

    The rate of patients in whom the sentinel node is detected

    24 months

Secondary Outcomes (1)

  • Negative predictive value

    24 months

Study Arms (1)

SENTINEL NODE

OTHER

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

Interventions

Sentinel node detectionPROCEDURE

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.

SENTINEL NODE

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis is a gynecologic study therefore only biologically female patients will be included
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Evidence of extraovarian disease
  • Allergy to the materials used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giovannni Scambia

Rome, Italy

Location

Related Publications (4)

  • 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.

    PMID: 29224846RESULT

  • 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.

    PMID: 29194194RESULT

  • 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.

    PMID: 28375928RESULT

  • 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.

    PMID: 31601646DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Giovanni Scambia, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2018

First Posted

June 20, 2018

Study Start

November 11, 2017

Primary Completion

July 29, 2022

Study Completion

May 5, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, 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

Locations

IT(1)