xml: <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/NCT06026631</url>
    </required_header>
    <id_info>
      <org_study_id>FPGemelliIRCCS4663</org_study_id>
      <nct_id>NCT06026631</nct_id>
    </id_info>
    <brief_title>Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.</brief_title>
    <acronym>BreCaLip</acronym>
    <official_title>Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to learn about breast cancer lipodome signature in&#xD;
        patients waiting for surgery with different Body Mass Index.&#xD;
  &#xD;
        The main question it aims to answer are:&#xD;
  &#xD;
          -  To highlight a specific lipidome molecular signature for breast cancer patients&#xD;
             overweight and obese (BMI &gt; 25 Kg/m2) compared with patients of normal weight (BMI&lt;25&#xD;
             kg/m2).&#xD;
  &#xD;
          -  Evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological&#xD;
             data of breast cancer patients and the correlation between molecular profile and body&#xD;
             weight.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">August 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation lipidome and BMI</measure>
      <time_frame>First day</time_frame>
      <description>Evaluate the correlation between some biomarkers derived from the lipidomic study (e.g. palmitic acid, stearic acid, oleic acid, palmitoleic acid and sapienic acid, arachidonic acid, dihomogammalinolenic acid, EPA, DHA, etc…) according to the BMI class considered.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation lipidome and nutrition/anatomical-pathological</measure>
      <time_frame>First day</time_frame>
      <description>Evaluate the correlation of molecular data with biochemical, nutritional and anatomical-pathological data of the patients and of the tumor (NLR -neutrophil-to-lymphocyte ratio), glycemia, cholesterol, blood pressure, triglycerides; TILs (percentage of lymphocytic infiltrate) and Ki67 (proliferation factor) on the surgical sample; W/H ratio, % FAT, % LEAN, phase angle at bioimpedance analysis in the study sample.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Lipid Cell; Tumor</condition>
    <condition>Nutrition Related Cancer</condition>
    <condition>Body Weight</condition>
    <arm_group>
      <arm_group_label>Intervention arm (breast cancer)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lipidomic analysis for breast cancer patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm (healthy subject)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Lipidomic analysis for healthy subjects</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lipidomic analysis for breast cancer patients</intervention_name>
      <description>Lipidomic analysis for breast cancer patients</description>
      <arm_group_label>Control arm (healthy subject)</arm_group_label>
      <arm_group_label>Intervention arm (breast cancer)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Patients&#xD;
  &#xD;
            -  Age &lt;65 years (not to have influence on functioning of desaturase enzymes that decline&#xD;
               with older ages).&#xD;
  &#xD;
            -  Neoplastic pathology: primary invasive breast cancer or ductal in situ (DCIS) newly&#xD;
               diagnosed, in the pre-operative phase and which has not already undergone chemo- or&#xD;
               radiotherapy.&#xD;
  &#xD;
            -  Absence of serious intestinal and hepatic pathologies, diabetes, both&#xD;
               insulin-dependent and in hypoglycaemic treatment or other pancreatic affection,&#xD;
               thyroid affections in pharmacological treatment.&#xD;
  &#xD;
            -  Absence of supplementation with omega-3 based supplements for at least 6 months.&#xD;
  &#xD;
            -  Homogeneous distribution by BMI (1:1 ratio subjects with BMI≥25 and BMI&lt;25,&#xD;
               respectively).&#xD;
  &#xD;
            -  Informed consent to participate in the study.&#xD;
  &#xD;
          controls&#xD;
  &#xD;
            -  Age &lt;65 years;&#xD;
  &#xD;
            -  Not be affected by cancer;&#xD;
  &#xD;
            -  BMI &lt;25kg/m2;&#xD;
  &#xD;
            -  Informed consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          patients&#xD;
  &#xD;
            -  Age ≥65 years (would affect the functioning of desaturase enzymes that decline with&#xD;
               older age).&#xD;
  &#xD;
            -  Invasive primary breast cancer or ductal in situ (DCIS) previously treated with chemo-&#xD;
               or radiotherapy.&#xD;
  &#xD;
            -  Metastasis at diagnosis.&#xD;
  &#xD;
            -  Presence of serious intestinal and hepatic pathologies.&#xD;
  &#xD;
            -  Presence of diabetes, both insulin-dependent and in hypoglycaemic treatment or other&#xD;
               pancreatic disease, thyroid disease in pharmacological treatment.&#xD;
  &#xD;
            -  Supplementation with omega-3 based supplements for at least 6 months.&#xD;
  &#xD;
            -  Failure to sign the informed consent to participate in the study.&#xD;
  &#xD;
          controls&#xD;
  &#xD;
            -  Age ≥65 years;&#xD;
  &#xD;
            -  Suffering from tumor pathology;&#xD;
  &#xD;
            -  BMI ≥25kg/m2;&#xD;
  &#xD;
            -  Refusal to sign informed consent to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stefano Magno, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione Policlinico Universitario A. Gemelli, IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stefano Magno, MD</last_name>
      <phone>+39 06 3015 7077</phone>
      <email>stefano.magno@policlinicogemelli.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alessio Filippone, Ph.D.</last_name>
      <phone>+39 06 3015 7077</phone>
      <email>alessio.filippone@guest.policlinicogemelli.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario A. Gemelli IRCCS</name>
        <address>
          <city>Roma</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Stefano magno, MD</last_name>
        <phone>+39 0630157077</phone>
        <email>stefano.magno@policlinicogemelli.it</email>
      </contact>
      <contact_backup>
        <last_name>Alessio Filippone, Ph.D.</last_name>
        <phone>+39 0630157077</phone>
        <email>alessio.filippone@guest.policlinicogemelli.it</email>
      </contact_backup>
      <investigator>
        <last_name>Stefano Magno, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Riccardo Masetti, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alessio Filippone, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Cristina Rossi, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maria M Rossi, M.Sc.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Claudia Maggiore, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Annalisa Di Micco, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Luana Forcina, M.Sc.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>Magno Stefano</investigator_full_name>
      <investigator_title>Head of UOS Breast Integrative Oncology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Body Weight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026631
  org study id: FPGemelliIRCCS4663
  nct id: NCT06026631
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about breast cancer lipodome signature in
        patients waiting for surgery with different Body Mass Index.
  
        The main question it aims to answer are:
  
          -  To highlight a specific lipidome molecular signature for breast cancer patients
             overweight and obese (BMI > 25 Kg/m2) compared with patients of normal weight (BMI<25
             kg/m2).
  
          -  Evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological
             data of breast cancer patients and the correlation between molecular profile and body
             weight.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Correlation lipidome and BMI
  time frame: First day
  description: Evaluate the correlation between some biomarkers derived from the lipidomic study (e.g. palmitic acid, stearic acid, oleic acid, palmitoleic acid and sapienic acid, arachidonic acid, dihomogammalinolenic acid, EPA, DHA, etc…) according to the BMI class considered.
  measure: Correlation lipidome and nutrition/anatomical-pathological
  time frame: First day
  description: Evaluate the correlation of molecular data with biochemical, nutritional and anatomical-pathological data of the patients and of the tumor (NLR -neutrophil-to-lymphocyte ratio), glycemia, cholesterol, blood pressure, triglycerides; TILs (percentage of lymphocytic infiltrate) and Ki67 (proliferation factor) on the surgical sample; W/H ratio, % FAT, % LEAN, phase angle at bioimpedance analysis in the study sample.
  arm group label: Intervention arm (breast cancer)
  arm group type: Experimental
  description: Lipidomic analysis for breast cancer patients
  arm group label: Control arm (healthy subject)
  arm group type: Other
  description: Lipidomic analysis for healthy subjects
  intervention type: Procedure
  intervention name: Lipidomic analysis for breast cancer patients
  description: Lipidomic analysis for breast cancer patients
  arm group label: Control arm (healthy subject)
  arm group label: Intervention arm (breast cancer)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stefano Magno, MD
  role: Principal Investigator
  affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
  last name: Stefano Magno, MD
  phone: +39 06 3015 7077
  email: stefano.magno@policlinicogemelli.it
  last name: Alessio Filippone, Ph.D.
  phone: +39 06 3015 7077
  email: alessio.filippone@guest.policlinicogemelli.it
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: Magno Stefano
  investigator title: Head of UOS Breast Integrative Oncology
  mesh term: Breast Neoplasms
  mesh term: Body Weight
  sharing ipd: No