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/NCT06020625</url>
    </required_header>
    <id_info>
      <org_study_id>3837</org_study_id>
      <nct_id>NCT06020625</nct_id>
    </id_info>
    <brief_title>Mutational Oncology in Clinical Practice</brief_title>
    <acronym>FPG-500</acronym>
    <official_title>Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.</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>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>
        The study of biological profiling is of fundamental importance in the diagnosis and treatment&#xD;
        of many diseases, particularly oncological ones, and for this reason, the integration of&#xD;
        molecular characterization into clinical practice becomes essential. NGS allows a high number&#xD;
        of samples to be sequenced simultaneously, generating a great deal of genomic information in&#xD;
        a short time and at reasonable cost. This information is of fundamental importance for the&#xD;
        study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive&#xD;
        role in response to new molecularly targeted drugs.&#xD;
  &#xD;
        Policlinico A. Gemelli has begun a process of internal reorganization of the research&#xD;
        infrastructure following its recognition in 2018 as an Institute of Hospitalization and&#xD;
        Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of&#xD;
        &quot;Personalized Medicine&quot; and &quot;Innovative Biotechnology.&quot; In particular, with regard to&#xD;
        genomics, will be equipped with a state-of-the-art technological asset that includes a fully&#xD;
        automated process for sample preparation and the highest gene sequencing power available&#xD;
        today. This condition makes it possible to perform extensive genomic profiling for large&#xD;
        numbers of patients at low cost and in reasonable time.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">January 2032</completion_date>
    <primary_completion_date type="Actual">May 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comprehensive Genome Profiling</measure>
      <time_frame>5 years</time_frame>
      <description>Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20000</enrollment>
    <condition>Genome Instability</condition>
    <condition>Genetic Predisposition to Disease</condition>
    <condition>Gene Rearrangement</condition>
    <arm_group>
      <arm_group_label>Interventional</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>Diagnostic Test</intervention_name>
      <description>In order to proceed with molecular characterization, the tumor sample already taken for histological diagnosis will undergo DNA and RNA extraction, which will be analyzed for qualitative and quantitative evaluation. Based on the quantitative data, the method to be used for profiling will be decided.&#xD;
  Multigenic genomic profiling will be performed for each patient on already taken tumor tissue using different panels depending on the quality and quantity of nucleic acids, in particular the following will be used: comprehensive Genome Profiling (CGP, ≥500 genes), if at least 40 ng of material is available; Profiling with identification of actionable mutations by targeted sequencing with panels of size &gt;50 genes, if &lt;40 ng material available.</description>
      <arm_group_label>Interventional</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          - Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum,&#xD;
          melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma:&#xD;
  &#xD;
            1. BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast&#xD;
               neoplasm, progressing after endocrine therapy.&#xD;
  &#xD;
            2. LUNG Metastatic disease.&#xD;
  &#xD;
            3. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary,&#xD;
               fallopian tube, or primary peritoneal carcinoma.&#xD;
  &#xD;
            4. PANCREAS Metastatic disease.&#xD;
  &#xD;
            5. PROSTATE Metastatic castration-resistant disease.&#xD;
  &#xD;
            6. COLORECTUM Metastatic disease.&#xD;
  &#xD;
            7. MELANOMA Stage IV or stage III undergoing surgery.&#xD;
  &#xD;
            8. GIST Profiling of c-KIT in case of metastatic disease or for patients undergoing&#xD;
               surgery and of PDGFRα for all patients with inoperable or metastatic disease.&#xD;
  &#xD;
            9. THYROID&#xD;
  &#xD;
           10. ENDOMETRIUM&#xD;
  &#xD;
           11. CHOLANGIOCARCINOMA&#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>Giovanni Scambia</last_name>
      <phone>0630158668</phone>
      <email>giovanni.scambia@policlinicogemelli.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Camilla Nero</last_name>
      <phone>0630158668</phone>
      <email>camilla.nero@policlinicogemelli.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
        <address>
          <city>Rome</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giovanni Scambia</last_name>
        <email>giovanni.scambia@policlinicogemelli.it</email>
      </contact>
      <contact_backup>
        <last_name>Camilla Nero</last_name>
        <email>camilla.nero@policlinicogemelli.it</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Genetic Predisposition to Disease</mesh_term>
      <mesh_term>Genomic Instability</mesh_term>
    </condition_browse>
    <!-- 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/NCT06020625
  org study id: 3837
  nct id: NCT06020625
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study of biological profiling is of fundamental importance in the diagnosis and treatment
        of many diseases, particularly oncological ones, and for this reason, the integration of
        molecular characterization into clinical practice becomes essential. NGS allows a high number
        of samples to be sequenced simultaneously, generating a great deal of genomic information in
        a short time and at reasonable cost. This information is of fundamental importance for the
        study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive
        role in response to new molecularly targeted drugs.
  
        Policlinico A. Gemelli has begun a process of internal reorganization of the research
        infrastructure following its recognition in 2018 as an Institute of Hospitalization and
        Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of
        "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to
        genomics, will be equipped with a state-of-the-art technological asset that includes a fully
        automated process for sample preparation and the highest gene sequencing power available
        today. This condition makes it possible to perform extensive genomic profiling for large
        numbers of patients at low cost and in reasonable time.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Comprehensive Genome Profiling
  time frame: 5 years
  description: Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre
  arm group label: Interventional
  arm group type: Experimental
  intervention type: Genetic
  intervention name: Diagnostic Test
  description: In order to proceed with molecular characterization, the tumor sample already taken for histological diagnosis will undergo DNA and RNA extraction, which will be analyzed for qualitative and quantitative evaluation. Based on the quantitative data, the method to be used for profiling will be decided.
  Multigenic genomic profiling will be performed for each patient on already taken tumor tissue using different panels depending on the quality and quantity of nucleic acids, in particular the following will be used: comprehensive Genome Profiling (CGP, ≥500 genes), if at least 40 ng of material is available; Profiling with identification of actionable mutations by targeted sequencing with panels of size >50 genes, if <40 ng material available.
  arm group label: Interventional
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Giovanni Scambia
  phone: 0630158668
  email: giovanni.scambia@policlinicogemelli.it
  last name: Camilla Nero
  phone: 0630158668
  email: camilla.nero@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Genetic Predisposition to Disease
  mesh term: Genomic Instability