SEntine Lymph Node in earLY Ovarian Cancer (SELLY) (SELLY)
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| ClinicalTrials.gov Identifier: NCT03563781 |
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Recruitment Status : Unknown
Verified March 2019 by Prof. Giovanni Scambia, Catholic University of the Sacred Heart.
Recruitment status was: Recruiting
First Posted : June 20, 2018
Last Update Posted : March 12, 2019
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| 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 |
| 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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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)
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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
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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 |
Inclusion Criteria:
- Epithelial ovarian cancer
- Early stage disease limited to the ovary
Exclusion Criteria:
- Evidence of extraovarian disease
- Allergy to the materials used
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, MD | +390630155629 | giovanni.scambia@policlinicogemelli.it | |
| Contact: Stefano Uccella, MD | +393496093970 | stefucc@libero.it |
| 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 | |
| Principal Investigator: | Giovanni Scambia, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ovarian cancer laparoscopy sentinel node lymphadenectomy |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |