<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/NCT03758976</url>
  </required_header>
  <id_info>
    <org_study_id>SCAN-B-rec</org_study_id>
    <nct_id>NCT03758976</nct_id>
  </id_info>
  <brief_title>Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)</brief_title>
  <official_title>SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective multicenter observational study to assess molecular drivers of metastatic breast&#xD;
      cancer and disease evolution upon therapeutic pressure.&#xD;
&#xD;
      The main aim is to develop and validate prognostic, predictive and pathogenic markers in&#xD;
      clinically well-characterized population-based material of breast cancer tumors and the&#xD;
      corresponding normal tissue.These data will be used to characterize recurrent breast cancer&#xD;
      on a molecular level, study tumor evolution, develop biomarkers of response/resistance to&#xD;
      targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical&#xD;
      studies and to elucidate mechanisms of resistance to therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>10 years</time_frame>
    <description>Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.</description>
  </primary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biopsies, blood</intervention_name>
    <description>We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer</description>
    <other_name>Targeted exon sequencing</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue biopsy, whole blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with metastatic, inoperable breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with pathologically confirmed advanced breast cancer (ABC), including locally&#xD;
             advanced inoperable disease and stage IV disease.&#xD;
&#xD;
          2. Age &gt; 18 years.&#xD;
&#xD;
          3. Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2.&#xD;
&#xD;
          4. ABC must be radiologically or clinically assessable, by means of at least one of the&#xD;
             following techniques: clinical examination, computerized tomography (CT-scan),&#xD;
             magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography&#xD;
             (PET).&#xD;
&#xD;
          5. Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion.&#xD;
&#xD;
          6. Signed informed consent according to ICH/GCP, and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Untreated psychiatric disorders that will impair the patient's ability to comply with study&#xD;
        treatment or protocol.&#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_contact>
    <last_name>Karolina Holm, PhD</last_name>
    <phone>+46 730 84 17 61</phone>
    <email>karolina.holm@med.lu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christel Reutersward, MSc</last_name>
    <email>christel.reutersward@med.lu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Lund University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karolina Holm, PhD</last_name>
      <phone>+46 730 84 47 61</phone>
      <email>karolina.holm@med.lu.se</email>
    </contact>
    <contact_backup>
      <last_name>Ana Bosch Campos, MD, PhD</last_name>
      <phone>+46 46 17 76 03</phone>
      <email>ana.bosch_campos@med.lu.se</email>
    </contact_backup>
    <investigator>
      <last_name>Åke Borg, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ana Bosch Campos, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anna-Maria Larsson, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lao Saal, Associated professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Johan Staaf, Associated professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lund University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karolina Holm, MSc</last_name>
      <phone>+46 730 84 47 61</phone>
      <email>karolina.holm@med.lu.se</email>
    </contact>
    <investigator>
      <last_name>Åke Borg, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic breast cancer</keyword>
  <keyword>Molecular profiling</keyword>
  <keyword>Circulating tumor DNA</keyword>
  <keyword>Circulating tumor cells</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/NCT03758976
org study id: SCAN-B-rec
nct id: NCT03758976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective multicenter observational study to assess molecular drivers of metastatic breast
      cancer and disease evolution upon therapeutic pressure.

      The main aim is to develop and validate prognostic, predictive and pathogenic markers in
      clinically well-characterized population-based material of breast cancer tumors and the
      corresponding normal tissue.These data will be used to characterize recurrent breast cancer
      on a molecular level, study tumor evolution, develop biomarkers of response/resistance to
      targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical
      studies and to elucidate mechanisms of resistance to therapy.
observational model: Cohort
time perspective: Prospective
measure: Survival
time frame: 10 years
description: Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.
intervention type: Diagnostic Test
intervention name: Biopsies, blood
description: We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer
other name: Targeted exon sequencing
Tissue biopsy, whole blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karolina Holm, PhD
phone: +46 730 84 17 61
email: karolina.holm@med.lu.se
last name: Christel Reutersward, MSc
email: christel.reutersward@med.lu.se
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
responsible party type: Sponsor
mesh term: Breast Neoplasms