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
NA
160 participants
INTERVENTIONAL
2019-10-23
2022-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Node-positive breast cancer patients
All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment
Systematic axillary ultrasound imaging
Before surgery, all patients will be explored with a pre-defined systematic and reproducible axillary ultrasound imaging workflow intending to establish the number of neoplastic lymph nodes.
Sentinel node
Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.
Excision of suspicious lymph nodes
Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.
Two steps axillary node clearance
Axillary node clearance will be performed in two steps comprising inferior and superior clearance. The second intercostobrachial nerve will be considered the limit defining the border between superior and inferior axilla.
Interventions
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Systematic axillary ultrasound imaging
Before surgery, all patients will be explored with a pre-defined systematic and reproducible axillary ultrasound imaging workflow intending to establish the number of neoplastic lymph nodes.
Sentinel node
Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.
Excision of suspicious lymph nodes
Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.
Two steps axillary node clearance
Axillary node clearance will be performed in two steps comprising inferior and superior clearance. The second intercostobrachial nerve will be considered the limit defining the border between superior and inferior axilla.
Eligibility Criteria
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Inclusion Criteria
* Positivity confirmed before the surgical treatment
Exclusion Criteria
* Inability to understand the protocol design
* Poor understanding of the Spanish language
18 Years
FEMALE
No
Sponsors
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GEICAM
UNKNOWN
Parc de Salut Mar
OTHER
Responsible Party
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Principal Investigators
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Maria Vernet-Tomas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Parc de Salut Mar
Locations
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Hospital del Mar
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Vernet-Tomas M, Banos N, Sabadell D, Corominas JM, Mestre-Fusco A, Suarez-Pinera M, Carreras R. p53 expression in breast cancer predicts tumors with low probability of non-sentinel nodes infiltration. J Obstet Gynaecol Res. 2015 Jul;41(7):1115-21. doi: 10.1111/jog.12670. Epub 2015 Feb 6.
Nicolau P, Gamero R, Rodriguez-Arana A, Plancarte F, Alcantara R, Carreras R, Sabadell D, Vernet-Tomas M. Imaging and pathology features to predict axillary tumor load in breast cancer. J Obstet Gynaecol Res. 2018 Feb;44(2):331-336. doi: 10.1111/jog.13490. Epub 2017 Oct 13.
Other Identifiers
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2018/8361/I
Identifier Type: -
Identifier Source: org_study_id