<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02197949</url>
  </required_header>
  <id_info>
    <org_study_id>ELISA</org_study_id>
    <nct_id>NCT02197949</nct_id>
  </id_info>
  <brief_title>Preoperative and Intraoperative Quantification of Axillary Tumoral Load</brief_title>
  <official_title>Preoperative and Intraoperative Quantification of Axillary Tumoral Load to Reduce the Need of Axillary Lymph Node Dissection in Breast Cancer Patients With Positive Lymph-nodes at Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parc de Salut Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Parc de Salut Mar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At present, patients diagnosed of a breast cancer with infiltration of the axillary&#xD;
      lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN)&#xD;
      technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the&#xD;
      surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The&#xD;
      reason for not performing SN is that patients diagnosed of an infiltrated axilla though&#xD;
      ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed&#xD;
      after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant&#xD;
      systemic treatment and the axillary clinical exploration is negative after the treatment,&#xD;
      different studies showed that the SN false negative rate is unacceptably high.&#xD;
&#xD;
      Despite these facts, a high proportion of patients with a positive axilla at diagnosis and&#xD;
      submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated&#xD;
      in the pathological study, frequently four or less neoplastic nodes. New methods of detecting&#xD;
      these patients with limited infiltrated nodes should be developed and new approaches to&#xD;
      axillary surgery (i.e., partial resection) should be offered.&#xD;
&#xD;
      To date, the only information expected to get after an axillary imaging is performed is if&#xD;
      the axilla is infiltrated or not. No information about the tumoral load is demanded. In the&#xD;
      other hand, level I and II ALND is performed according to established anatomic limits,&#xD;
      without selecting the nodes to be excised neither identifying the ones infiltrated for a&#xD;
      directed excision.&#xD;
&#xD;
      The aim of the study is to evaluate the ability of a specified and reproducible imaging&#xD;
      protocol for distinguishing patients with a high axillary tumoral load from the ones with a&#xD;
      low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be&#xD;
      the ones commonly affected, identifying these nodes injecting diluted methylene blue in the&#xD;
      retroareolar parenchyma and studying their tumoral load could help selecting patients with&#xD;
      high from those with low axillary tumoral load.&#xD;
&#xD;
      Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue&#xD;
      protocol), could eventually help to distinguish which patients should be submitted to a&#xD;
      classical level I and II ALND and which ones can be spared from excising the lymph nodes not&#xD;
      stained by the methylene blue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recuitment&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Axillary tumoral load</measure>
    <time_frame>During surgery (one evaluation)</time_frame>
    <description>-Accuracy to detect patients with low axillary tumoral load (in terms of sensibility and specificity) of a protocol including systematic a reproducible axillary imaging and identification of the first axillary nodes through methylene blue retroareolar injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Methylene blue injection to identify nodes of the lymphatic drainage.</measure>
    <time_frame>During surgery (one evaluation)</time_frame>
    <description>-Identification of clinical data influencing accuracy of methylene blue injection to identify the first four to six lymph nodes of the lymphatic drainage.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Breast cancer patients with infiltrated axillary l</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast cancer patients with infiltrated axillary lymph nodes cT1-4 cN1&#xD;
&#xD;
          -  Older than 18 years old&#xD;
&#xD;
          -  Able to understand and accept the protocol procedure and to sign an informed consent&#xD;
             form in accordance with national legislation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breast cancer patients in whom no information about axillary lymph nodes status&#xD;
             (cytology or biopsy) is available.&#xD;
&#xD;
          -  Patients younger than 18 years old.&#xD;
&#xD;
          -  Psychiatric disease&#xD;
&#xD;
          -  Difficulties to understand Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria del Mar Vernet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parc de Salut Mar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>November 7, 2016</last_update_submitted>
  <last_update_submitted_qc>November 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Parc de Salut Mar</investigator_affiliation>
    <investigator_full_name>Maria del Mar Vernet</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197949
org study id: ELISA
nct id: NCT02197949
lead sponsor: 
has dmc: No
At present, patients diagnosed of a breast cancer with infiltration of the axillary
      lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN)
      technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the
      surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The
      reason for not performing SN is that patients diagnosed of an infiltrated axilla though
      ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed
      after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant
      systemic treatment and the axillary clinical exploration is negative after the treatment,
      different studies showed that the SN false negative rate is unacceptably high.

      Despite these facts, a high proportion of patients with a positive axilla at diagnosis and
      submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated
      in the pathological study, frequently four or less neoplastic nodes. New methods of detecting
      these patients with limited infiltrated nodes should be developed and new approaches to
      axillary surgery (i.e., partial resection) should be offered.

      To date, the only information expected to get after an axillary imaging is performed is if
      the axilla is infiltrated or not. No information about the tumoral load is demanded. In the
      other hand, level I and II ALND is performed according to established anatomic limits,
      without selecting the nodes to be excised neither identifying the ones infiltrated for a
      directed excision.

      The aim of the study is to evaluate the ability of a specified and reproducible imaging
      protocol for distinguishing patients with a high axillary tumoral load from the ones with a
      low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be
      the ones commonly affected, identifying these nodes injecting diluted methylene blue in the
      retroareolar parenchyma and studying their tumoral load could help selecting patients with
      high from those with low axillary tumoral load.

      Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue
      protocol), could eventually help to distinguish which patients should be submitted to a
      classical level I and II ALND and which ones can be spared from excising the lymph nodes not
      stained by the methylene blue.
observational model: Cohort
time perspective: Prospective
measure: Axillary tumoral load
time frame: During surgery (one evaluation)
description: -Accuracy to detect patients with low axillary tumoral load (in terms of sensibility and specificity) of a protocol including systematic a reproducible axillary imaging and identification of the first axillary nodes through methylene blue retroareolar injection.
measure: Methylene blue injection to identify nodes of the lymphatic drainage.
time frame: During surgery (one evaluation)
description: -Identification of clinical data influencing accuracy of methylene blue injection to identify the first four to six lymph nodes of the lymphatic drainage.
arm group label: Breast cancer patients with infiltrated axillary l
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria del Mar Vernet, MD, PhD
role: Principal Investigator
affiliation: Parc de Salut Mar
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Parc de Salut Mar
investigator full name: Maria del Mar Vernet
investigator title: MD
mesh term: Breast Neoplasms
sharing ipd: No