SEntine Lymph Node in earLY Ovarian Cancer (SELLY) (SELLY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03563781|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sentinel Lymph Node Ovarian Cancer Stage I||Procedure: Sentinel node detection||Not Applicable|
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 (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)|
|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|
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.
- 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
- Negative predictive value [ Time Frame: 24 months ]The negative predictive value of sentinel node in assessing nodal status
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
|Contact: Giovanni Scambia Scambia, MDfirstname.lastname@example.org|
|Contact: Stefano Uccella, MDemail@example.com|
|Nuovo Ospedale degli Infermi||Not yet recruiting|
|Biella, Italy, 13875|
|Contact: Gianni Bonelli +3901515151 firstname.lastname@example.org|
|Contact: Stefano Uccella +393496093970 email@example.com|
|Fondazione di Ricerca e Cura 'Giovanni Paolo II'||Recruiting|
|Campobasso, Italy, 86100|
|Contact: Francesco Cosentino +393391194708 firstname.lastname@example.org|
|Contact: Luigi Turco +390874312497 email@example.com|
|Istituto Regina Elena IRCCS||Recruiting|
|Roma, Italy, 00144|
|Contact: Enrico Vizza, MD 06-52661 firstname.lastname@example.org|
|Contact: Giacomo Corrado, MD 06 52666657 email@example.com|
|Policlinico Universitario Agostino Gemelli||Recruiting|
|Roma, Italy, 00168|
|Contact: Giovanni Scambia, MD +390630155629 firstname.lastname@example.org|
|Contact: Stefano Uccella, MD +393496093970 email@example.com|
|Principal Investigator:||Giovanni Scambia, MD||Fondazione Policlinico Universitario Agostino Gemelli IRCCS|