SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

NCT03563781CompletedNAINTERVENTIONAL

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

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

176

Start Date

2017-11-11

Completion Date

2022-07-29

Study Type

INTERVENTIONAL

Official Title

SEntine Lymph Node in earLY Ovarian Cancer

Interventions

Sentinel node detection

Conditions

Sentinel Lymph NodeOvarian Cancer Stage I

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

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

Exclusion Criteria:

* Evidence of extraovarian disease
* Allergy to the materials used

Outcome Measures

Primary Outcomes

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

Secondary Outcomes

Negative predictive value

The negative predictive value of sentinel node in assessing nodal status

Time frame: 24 months

Locations

Giovannni Scambia, Rome, Italy