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Sentinel Lymph Node Technique in Multifocal Breast Cancer

Study acronym: IGASSU
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Eligibility criteria expanded, about 15 words

    Study description expanded, about 5 words; Site details revised at 1 of 20 sites

    Show what changed: Eligibility criteria
    Inclusion Criteria: * Multifocal invasive breast cancer * At least 2 focuses (clinically and/or by mammography or ultrasound) * Proven by pre-surgical histology (on 1 focus at least) * Age \> 18 years old * Clinically negative axillary lymph nodes * No treatment before surgery * Signature of written informed consent Exclusion Criteria: * Multifocality proven after surgery * Non invasive breast cancer * Inflammatory breast cancer * Axillary lymph node * Metastatic disease * Previous homolateral breast cancer * Dementia or alterated mental status * Pregnant or lactating woman
    Show what changed: Study description
    The sentinel lymph node is located preferentially by: * association of subareolar injection of technecium and blue dye * or, in case of blue dye allergy, by the subareolar injection of technecium only * or, in case of no possibility of radioactive isotope subareo [...] e made the day before the surgery or the day of the surgery * This procedure is immediately follows by complete axillary dissection during breast surgery * The anatomopathologic analysis of the 2 samples (sentinel ly [...]

  2. Notable

    Primary and study completion dates: Sep 2008 to Aug 13, 2010

    Study Identification, Study Status, Sponsor/Collaboratorsv4

  3. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v3

  4. Minor

    Trial status: Recruiting to Completed

    Enrollment target: 203 to 216; Study sites: 17 to 20; Primary completion date: Sep 2008; and 4 more

    Show all 8 changes in this update
    • Minor Trial status: Recruiting to Completed
    • Minor Enrollment target: 203 to 216
    • Minor Study sites: 17 to 20
    • Minor Primary completion date: Sep 2008
    • Minor Completion date: Mar 2008 to Sep 2008
    • Minor Start date: Feb 2006 to Mar 2006
    • Minor Secondary endpoints: details revised at 2 of 2 entries
    • Minor Study description expanded, about 105 words
      Show what changed
      FurtherThe sentinel lymph node is located preferentially by: association of subareolar injection of technecium and blue dye or, in case of blue dye allergy, by the subareolar injection of technecium only or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only [...] study detailsfor asthe provided by Centre Oscar Lambretpatient.

    Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Outcome Measures, Contacts/Locationsv2

  5. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer
Trial Details
NCT Number NCT00417495
Lead Sponsor Centre Oscar Lambret
Conditions Breast Cancer
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov