SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY
NCT ID: NCT04250129
Last Updated: 2020-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2018-01-31
2023-01-31
Brief Summary
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Detailed Description
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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:
1. SLNB (-) \& RT
2. SLNB (+) \& RT
3. SLNB (+) \& ALND \& RT Radiotherapy details will be announced as supplementary
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SLNB (-)&level 1-3 RT
SLNB (-)\&level 1-3 RT
No interventions assigned to this group
SLNB (+)&level 1-3 RT
SLNB (+)\&level 1-3 RT
No interventions assigned to this group
SLNB(+)&ALND&level 3 RT (+/-level 1-2)
SLNB(+)\&ALND\&level 3 RT (+/-level 1-2)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
FEMALE
Yes
Sponsors
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Federation of Breast Diseases Societies
OTHER
Responsible Party
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Principal Investigators
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Neslihan Cabioglu, Prof
Role: PRINCIPAL_INVESTIGATOR
Istanbul University
Hasan Karanlik
Role: STUDY_DIRECTOR
Istanbul University Institute of Oncology
Guldeniz Karadeniz Cakmak
Role: STUDY_CHAIR
Bulent Ecevit University Faculty of Medicine
Locations
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Istanbul University Institute of Oncology
Istanbul, , Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Bulent Ecevit University Faculty of Medicine
Zonguldak, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Hasan Karanlik, Prof
Role: primary
Neslihan Cabioglu, Prof
Role: primary
Guldeniz Karadeniz Cakmak, Prof
Role: primary
Guldeniz Karadeniz Cakmak
Role: backup
Other Identifiers
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2018-03
Identifier Type: -
Identifier Source: org_study_id