Sentinel Lymph NodeSELLYNCT03563781
SEntine Lymph Node in earLY Ovarian Cancer (SELLY)
A study testing Sentinel node detection in people with Sentinel Lymph Node and Ovarian Cancer Stage I, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Sentinel Lymph Node, Ovarian Cancer Stage I
- What is being tested?
- Sentinel node detection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2017to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epithelial ovarian cancer
- Early stage disease limited to the ovary
Who cannot join
- Evidence of extraovarian disease
- Allergy to the materials used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SEntine Lymph Node in earLY Ovarian Cancer
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
Read the 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.
- Conditions
- Sentinel Lymph Node, Ovarian Cancer Stage I
- Being tested
- Sentinel node detection
- Keywords
- ovarian cancer, laparoscopy, sentinel node, lymphadenectomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node detectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Sentinel node detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with procedure-related adverse events
The number of patients with procedure-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Detection rate
The rate of patients in whom the sentinel node is detected
Measured: 24 months
Secondary outcomes (1)
Negative predictive value
The negative predictive value of sentinel node in assessing nodal status
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start11 Nov 2017
- Primary completion29 Jul 2022
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SCAMBIA GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giovanni Scambia, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563781
- Sponsor's protocol ID
- CICOG-2-3-18/12
- Acronym
- SELLY
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared only with those making official request to the study investigator
Publications
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.
PubMed 29224846Sadeghi 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.
PubMed 29194194Nyberg 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.
PubMed 28375928Scambia 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.
PubMed 31601646
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEntine Lymph Node in earLY Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03563781
- Acronym / sponsor ID
- SELLY / CICOG-2-3-18/12
- Conditions
- Sentinel Lymph Node, Ovarian Cancer Stage I
- Keywords
- ovarian cancer, laparoscopy, sentinel node, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| SENTINEL NODE | Other | Procedure: Sentinel node detectionPatients 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Epithelial ovarian cancer
- Early stage disease limited to the ovary
Key exclusion criteria (2 listed)
- Evidence of extraovarian disease
- Allergy to the materials used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel node detectionPatients 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. | Procedure or surgery | SENTINEL NODE |
Primary outcome
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
1 secondary outcome
Negative predictive value
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 29224846Uccella 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.
- Results publication: PubMed 29194194Sadeghi 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.
- Results publication: PubMed 28375928Nyberg 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.
- Derived from this study: PubMed 31601646Scambia 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.
- Individual participant dataSharing planned: Yes. The IPD will be shared only with those making official request to the study investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Scambia, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node detection in people with Sentinel Lymph Node and Ovarian Cancer Stage I, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with procedure-related adverse events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03563781, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.