Ovarian CancerNCT04714931
Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
A study testing Sentinel lymph node detection in people with Ovarian Cancer and Sentinel Lymph Node, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Sentinel Lymph Node
- What is being tested?
- Sentinel lymph node detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Apr 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Early stage ovarian cancer
Who cannot join
- Patient who had been administrated chemotherapy prior to surgery
- Patients who had diagnosed with malignancy other than ovarian cancer.
- Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
- Patients who have allergy for the tracers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem MAA University Maslak Hospital
Istanbul, 34457
Ozguc Takmaz, Assist.Prof., +905554006591, ozguctakmaz@hotmail.com
Mete Gungor, Prof., +902123044970, mete.gungor@acibadem.com
About this study
Official title: Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)
The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.
Read the detailed description
Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.
Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.
- Conditions
- Ovarian Cancer, Sentinel Lymph Node
- Being tested
- Sentinel lymph node detection
- 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 lymph node detectionDiagnostic test
Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node | Other | Sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice. Receives: Diagnostic Test: Sentinel lymph node detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node localization
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
Measured: 12 months
Sentinel lymph node technique accuracy in ovarian cancer
Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
Measured: 12 months
PPV and NPV of sentinel lymph node procedure in ovarian cancer
Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
Measured: 12 months
Adverse events
Adverse events related with sentinel lymph node procedure in ovarian cancer
Measured: 12 months
Sentinel lymph node detection rate
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
Measured: 12 months
Secondary outcomes (2)
Tracer comparisons
Detection rate differences between different tracers
Measured: 12 months
Assessment of the sentinel tecniques
Evaluation of the tracer injection techniques whether before the excision of the mass or after the excision of the mass for the effectiveness of sentinel lymph node detection.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- Prospective, Controlled, not randomized
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozguc Takmaz, Acibadem University
- Investigators
- Mete Gungor, Prof., Study director, Acibadem MAA University Maslak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714931
- Sponsor's protocol ID
- TRSGO-SLN-OO5
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)
- ClinicalTrials.gov ID
- NCT04714931
- Acronym / sponsor ID
- TRSGO-SLN-OO5
- Conditions
- Ovarian Cancer, Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 20 Jan 2021 (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 aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.
Detailed description
Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.
Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Controlled, not randomized
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node | Other | Diagnostic Test: Sentinel lymph node detectionSentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Early stage ovarian cancer
Key exclusion criteria (4 listed)
- Patient who had been administrated chemotherapy prior to surgery
- Patients who had diagnosed with malignancy other than ovarian cancer.
- Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
- Patients who have allergy for the tracers.
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 lymph node detectionTracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice. | Diagnostic test | Sentinel Lymph Node |
Primary outcome
Sentinel lymph node localization
Time frame: 12 months
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
Sentinel lymph node technique accuracy in ovarian cancer
Time frame: 12 months
Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
PPV and NPV of sentinel lymph node procedure in ovarian cancer
Time frame: 12 months
Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
Adverse events
Time frame: 12 months
Adverse events related with sentinel lymph node procedure in ovarian cancer
Sentinel lymph node detection rate
Time frame: 12 months
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
2 secondary outcomes
Tracer comparisons
Time frame: 12 months
Assessment of the sentinel tecniques
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
Mete Gungor, Prof. study director
Acibadem MAA University Maslak Hospital
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 lymph node detection in people with Ovarian Cancer and Sentinel Lymph Node, run by Acibadem University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozguc Takmaz, Assist.Prof (+905554006591, ozguctakmaz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel lymph node localization (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.