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

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

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

Condition or disease Intervention/treatment Phase
Sentinel Lymph Node Ovarian Cancer Stage I Procedure: Sentinel node detection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
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
Official Title: SEntine Lymph Node in earLY Ovarian Cancer
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

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


Secondary Outcome Measures :
  1. Negative predictive value [ Time Frame: 24 months ]
    The negative predictive value of sentinel node in assessing nodal status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Evidence of extraovarian disease
  • Allergy to the materials used

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563781


Contacts
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Contact: Giovanni Scambia Scambia, MD +390630155629 giovanni.scambia@policlinicogemelli.it
Contact: Stefano Uccella, MD +393496093970 stefucc@libero.it

Locations
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Italy
Nuovo Ospedale degli Infermi Not yet recruiting
Biella, Italy, 13875
Contact: Gianni Bonelli    +3901515151    gianni.bonelli@aslbi.it   
Contact: Stefano Uccella    +393496093970    stefucc@libero.it   
Fondazione di Ricerca e Cura 'Giovanni Paolo II' Recruiting
Campobasso, Italy, 86100
Contact: Francesco Cosentino    +393391194708    francesco.cosentino@policlinicogemelli.it   
Contact: Luigi Turco    +390874312497    luigi.turco@policlinicogemelli.it   
Istituto Regina Elena IRCCS Recruiting
Roma, Italy, 00144
Contact: Enrico Vizza, MD    06-52661    vizzaenrico@me.it   
Contact: Giacomo Corrado, MD    06 52666657    giacomo.corrado@alice.it   
Policlinico Universitario Agostino Gemelli Recruiting
Roma, Italy, 00168
Contact: Giovanni Scambia, MD    +390630155629    giovanni.scambia@policlinicogemelli.it   
Contact: Stefano Uccella, MD    +393496093970    stefucc@libero.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Giovanni Scambia, MD Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03563781    
Other Study ID Numbers: CICOG-2-3-18/12
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (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
Informed Consent Form (ICF)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
ovarian cancer
laparoscopy
sentinel node
lymphadenectomy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type