<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/NCT01669265</url>
  </required_header>
  <id_info>
    <org_study_id>SOLTI-1113</org_study_id>
    <nct_id>NCT01669265</nct_id>
  </id_info>
  <brief_title>Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer</brief_title>
  <acronym>SOLO-1</acronym>
  <official_title>Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SOLTI Breast Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sysmex America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SOLTI Breast Cancer Research Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early&#xD;
      breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by&#xD;
      one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.&#xD;
&#xD;
      The aim of the present study is to assess the intraoperative positive SLN total tumor load&#xD;
      (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN&#xD;
      metastasis in patients with clinically node-negative early-stage breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the negative predictive value of the technique OSNA.</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ROC curve that describes the assay</measure>
    <time_frame>At time of surgery</time_frame>
    <description>ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the assay</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of the assay</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Probability that OSNA in SLN is negative because there is no involvement of NSLN</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likelihood ratio for the cutoff of 10,000-15,000 copies/uL</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Likelihood ratio of positive and negative results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive predictive value at the cutoff of 10.000-15.000 copies/μL.</measure>
    <time_frame>At time of surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">701</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>OSNA</arm_group_label>
    <description>Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cT1-3, N0 breast cancer, who had intraoperative SLN evaluation by OSNA assay&#xD;
        with a complete axillary lymph node dissection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed invasive breast carcinoma&#xD;
&#xD;
          -  Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best&#xD;
             clinical local practices&#xD;
&#xD;
          -  Intraoperative evaluation of sentinel lymph node (SLN) by OSNA&#xD;
&#xD;
          -  Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA&#xD;
&#xD;
          -  Pathology report of the tumor and dissected lymph nodes that includes the following&#xD;
             information:&#xD;
&#xD;
               -  primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor&#xD;
                  status&#xD;
&#xD;
               -  progesterone receptor status&#xD;
&#xD;
               -  HER2 status (ASCO/CAP guidelines)&#xD;
&#xD;
               -  Ki67 index&#xD;
&#xD;
               -  presence/absence of lymphovascular invasion&#xD;
&#xD;
               -  total number of sentinel and non-sentinel lymph nodes dissected during surgery&#xD;
&#xD;
               -  total number of positive and negative sentinel and non-sentinel lymph nodes,&#xD;
                  *size of the metastasis in both sentinel and non-sentinel lymph nodes&#xD;
&#xD;
               -  total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA&#xD;
                  copies per microliter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent neoadjuvant chemotherapy&#xD;
&#xD;
          -  CK19-negative breast tumor&#xD;
&#xD;
          -  ALND with &lt;10 lymph nodes&#xD;
&#xD;
          -  In situ carcinoma only&#xD;
&#xD;
          -  Metastatic breast cancer at time of diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vicente Peg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d´Hebron University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabel Rubio, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vall d´Hebron University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Espinosa-Bravo, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vall d´Hebron University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d´Hebron University Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>La Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria Doctor Negrin</name>
      <address>
        <city>Las Palmas</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Arnau de Vilanova</name>
      <address>
        <city>Lleida</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Del Rocio</name>
      <address>
        <city>Seville</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.gruposolti.org</url>
    <description>SOLTI Breast Cancer Research Group</description>
  </link>
  <results_reference>
    <citation>Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11.</citation>
    <PMID>23576079</PMID>
  </results_reference>
  <results_reference>
    <citation>Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JJ, Salas MS, Sansano I, Delgado Sánchez JJ, Pinto W, Gozalbo F, Petit A, Rubio I. Intraoperative molecular analysis of sentinel lymph node as a new predictor of axillary status in early breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.</citation>
  </results_reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>May 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>OSNA</keyword>
  <keyword>sentinel lymph node</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01669265
org study id: SOLTI-1113
nct id: NCT01669265
lead sponsor: 
collaborator: 
has dmc: No
This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early
      breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by
      one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.

      The aim of the present study is to assess the intraoperative positive SLN total tumor load
      (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN
      metastasis in patients with clinically node-negative early-stage breast cancer.
observational model: Cohort
time perspective: Retrospective
measure: Estimate the negative predictive value of the technique OSNA.
time frame: At time of surgery
description: Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.
measure: ROC curve that describes the assay
time frame: At time of surgery
description: ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs
measure: Sensitivity of the assay
time frame: At time of surgery
description: Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)
measure: Specificity of the assay
time frame: At time of surgery
description: Probability that OSNA in SLN is negative because there is no involvement of NSLN
measure: Likelihood ratio for the cutoff of 10,000-15,000 copies/uL
time frame: At time of surgery
description: Likelihood ratio of positive and negative results
measure: Positive predictive value at the cutoff of 10.000-15.000 copies/μL.
time frame: At time of surgery
arm group label: OSNA
description: Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Vicente Peg, MD
role: Principal Investigator
affiliation: Vall d´Hebron University Hospital
last name: Isabel Rubio, MD, PhD
role: Study Chair
affiliation: Vall d´Hebron University Hospital
last name: Martin Espinosa-Bravo, MD, PhD
role: Study Chair
affiliation: Vall d´Hebron University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
url: http://www.gruposolti.org
description: SOLTI Breast Cancer Research Group
citation: Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11.
PMID: 23576079
citation: Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JJ, Salas MS, Sansano I, Delgado Sánchez JJ, Pinto W, Gozalbo F, Petit A, Rubio I. Intraoperative molecular analysis of sentinel lymph node as a new predictor of axillary status in early breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.
responsible party type: Sponsor
mesh term: Breast Neoplasms