Sentinel Lymph NodeNEOSENTITURKNCT04250129
SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY
An observational study of Sentinel Lymph Node, run by Federation of Breast Diseases Societies at 3 sites in Turkey (Türkiye).
Trial summary
Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sentinel Lymph Node
- How many people
- 500 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 31 Jan 2018to 31 Jan 2023
- Phase
- Observational
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recomended.
Who may be able to join
- T0-4, N1-3, M0
Who cannot join
- Inflammatory breast cancer, pregnant patients Patients with metastatic disease
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Istanbul University Institute of Oncology
Istanbul
Hasan Karanlik, Prof, +905324025354, hasankaranlik@yahoo.com
- Recruiting
Istanbul University Istanbul Faculty of Medicine
Istanbul
Neslihan Cabioglu, Prof
Abdullah Igci, Prof
- Recruiting
Bulent Ecevit University Faculty of Medicine
Zonguldak
Guldeniz Karadeniz Cakmak, Prof, 05323371860
Guldeniz Karadeniz Cakmak
About this study
Official title: IS SENTINEL LYMPH NODE BIOPSY WITH RADIOTHERAPY ALONE WITHOUT AXILLARY LYMPH NODE DISSECTION SAFE FOLLOWING NEOADJUVANT CHEMOTHERAPY IN INITIALLY CLINICALLY AXILLA POSITIVE PATIENTS: NEOSENTITURK-TRIAL/MF-18-03
Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. In this study, the investigators evaluated factors affecting local recurrence and outcome in patients with locally advanced breast cancer (LABC), who underwent sentinel lymph node (SLN) with or without ALND after NAC.
Read the detailed description
All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. Axillary fine needle aspiration biopsy or Trucut biopsy is mandatory.
All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recommended.
All patients with clinally-negative axilla and underwent SLNB will be included into the study:
- SLNB (-) \& RT
- SLNB (+) \& RT
- SLNB (+) \& ALND \& RT Radiotherapy details will be announced as supplementary
- Conditions
- Sentinel Lymph Node
- Keywords
- sentinel lymph node biopsy, Neoadjuvan chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLNB (-)&level 1-3 RT | SLNB (-)\&level 1-3 RT | |
| SLNB (+)&level 1-3 RT | SLNB (+)\&level 1-3 RT | |
| SLNB(+)&ALND&level 3 RT (+/-level 1-2) | SLNB(+)\&ALND\&level 3 RT (+/-level 1-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence free survival
Breast and axillary recurrence rates
Measured: January 2023
Secondary outcomes (2)
Disease free survival
Local recurrence and distant metastasis rates
Measured: January 2023
Overall survival
Overall survival
Measured: January 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start31 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation of Breast Diseases Societies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neslihan Cabioglu, Prof, Principal investigator, Istanbul UniversityHasan Karanlik, Study director, Istanbul University Institute of OncologyGuldeniz Karadeniz Cakmak, Study chair, Bulent Ecevit University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250129
- Sponsor's protocol ID
- 2018-03
- Acronym
- NEOSENTITURK
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS SENTINEL LYMPH NODE BIOPSY WITH RADIOTHERAPY ALONE WITHOUT AXILLARY LYMPH NODE DISSECTION SAFE FOLLOWING NEOADJUVANT CHEMOTHERAPY IN INITIALLY CLINICALLY AXILLA POSITIVE PATIENTS: NEOSENTITURK-TRIAL/MF-18-03
- ClinicalTrials.gov ID
- NCT04250129
- Acronym / sponsor ID
- NEOSENTITURK / 2018-03
- Conditions
- Sentinel Lymph Node
- Keywords
- sentinel lymph node biopsy, Neoadjuvan chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Federation of Breast Diseases SocietiesUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 31 Jan 2020 (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.
Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. In this study, the investigators evaluated factors affecting local recurrence and outcome in patients with locally advanced breast cancer (LABC), who underwent sentinel lymph node (SLN) with or without ALND after NAC.
Detailed description
All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. Axillary fine needle aspiration biopsy or Trucut biopsy is mandatory.
All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recommended.
All patients with clinally-negative axilla and underwent SLNB will be included into the study:
- SLNB (-) \& RT
- SLNB (+) \& RT
- SLNB (+) \& ALND \& RT Radiotherapy details will be announced as supplementary
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLNB (-)&level 1-3 RT | – | –SLNB (-)\&level 1-3 RT |
| SLNB (+)&level 1-3 RT | – | –SLNB (+)\&level 1-3 RT |
| SLNB(+)&ALND&level 3 RT (+/-level 1-2) | – | –SLNB(+)\&ALND\&level 3 RT (+/-level 1-2) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recomended.
Key inclusion criteria (1 listed)
- T0-4, N1-3, M0
Key exclusion criteria (1 listed)
- Inflammatory breast cancer, pregnant patients Patients with metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local recurrence free survival
Time frame: January 2023
Breast and axillary recurrence rates
2 secondary outcomes
Disease free survival
Time frame: January 2023
Overall survival
Time frame: January 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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27-Inch Versus 55-Inch Monitors in Women Undergoing Endometrial Cancer Surgery
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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.
Neslihan Cabioglu, Prof principal investigator
Istanbul University
Hasan Karanlik study director
Istanbul University Institute of Oncology
Guldeniz Karadeniz Cakmak study chair
Bulent Ecevit University Faculty of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node, run by Federation of Breast Diseases Societies at 3 sites 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 1 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 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Neslihan Cabioglu, Prof (+905325057724, ncabioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence free survival (time frame: January 2023). 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 31 Jan 2020.