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/NCT06028724</url>
    </required_header>
    <id_info>
      <org_study_id>CRO-2022-51</org_study_id>
      <nct_id>NCT06028724</nct_id>
    </id_info>
    <brief_title>A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)</brief_title>
    <acronym>POPCORN</acronym>
    <official_title>A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro di Riferimento Oncologico - Aviano</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro di Riferimento Oncologico - Aviano</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The implementation of liquid biopsy in clinical practice has been favored by the rapid&#xD;
        development of genome sequencing techniques designed to analyze mutations in ctDNA. Among&#xD;
        these, the Next generation sequencing (NGS) is a technique that consists in sequencing&#xD;
        several genomes in a short time span, collecting information about a wider range of genomic&#xD;
        alterations, using small quantities of genetic material. It is used to identify potential&#xD;
        circulating dynamic biomarkers of treatment sensitivity or resistance in a real word&#xD;
        multi-pathology evaluation. In this way, defining the mutational status of clinical relevance&#xD;
        genes in real world, as a predictive biomarker to identify those patients most likely to&#xD;
        benefit from target therapy, offers the potential to optimize access to further therapies.&#xD;
        The aim of this study is to evaluate the real-world prevalence of clinically useful mutations&#xD;
        in patients who are receiving therapy for advanced and locally advanced solid tumor through&#xD;
        liquid biopsy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 26, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2030</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>Real world prevalence of clinically useful mutations in solid tumors</measure>
      <time_frame>at the beginning of treatment</time_frame>
      <description>Real world prevalence of clinically useful mutations in solid tumors, defined as the proportion of patients with the detection of clinically useful mutations through ctDNA NGS, at the beginning of systemic therapies defined as per inclusion criteria for advanced disease.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To identify emerging gene alterations associated with Progression Free Survival</measure>
      <time_frame>from study enrollment until progression or death for any cause, up to 7 years</time_frame>
      <description>To identify emerging gene alterations associated with Progression Free Survival (PFS) defined as the time from study enrollment until progression or death for any cause, whichever comes first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To identify emerging gene alterations associated with Overall Survival</measure>
      <time_frame>from study enrollment until death for any cause, up to 7 years</time_frame>
      <description>To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To describe changes in ctDNA associated biomarkers during treatment</measure>
      <time_frame>up to 7 years</time_frame>
      <description>Difference in frequency of patients with ctDNA associated biomarkers at different time point during treatment (at baseline, at start of cycle 2, at first radiological evaluation, at relapse or end of follow-up)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the association between somatic genetic alterations and the histopathological features of the tumor</measure>
      <time_frame>up to 7 years</time_frame>
      <description>Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the association between somatic genetic alterations and pattern of metastasis</measure>
      <time_frame>up to 7 years</time_frame>
      <description>Frequency of somatic genetic alterations in subgroups of patients with metastasis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients</measure>
      <time_frame>up to 7 years</time_frame>
      <description>Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics</description>
    </secondary_outcome>
    <enrollment type="Anticipated">782</enrollment>
    <condition>Solid Tumor</condition>
    <condition>Advanced Solid Tumor</condition>
    <condition>Locally Advanced Solid Tumor</condition>
    <condition>Colon Rectal Cancer</condition>
    <condition>Gastric Cancer</condition>
    <condition>Pancreatic Cancer</condition>
    <condition>Bile Duct Cancer</condition>
    <condition>Hepatocarcinoma</condition>
    <condition>Breast Cancer</condition>
    <condition>Ovarian Cancer</condition>
    <condition>Endometrial Cancer</condition>
    <condition>Cervical Cancer</condition>
    <condition>Vulva Cancer</condition>
    <condition>Melanoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are receiving therapy for advanced and locally advanced solid tumor as&#xD;
          specified in eligibility criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients eligible for inclusion in this study have to meet all of the following criteria:&#xD;
  &#xD;
            -  Patients, 18 years of age or older&#xD;
  &#xD;
            -  Competent and able to comprehend, sign and date an Ethics Committee (EC) approved&#xD;
               Informed Consent Form (ICF) before performance of any study-specific procedures or&#xD;
               tests&#xD;
  &#xD;
            -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,&#xD;
               and other study procedures&#xD;
  &#xD;
            -  Histologically proven diagnosis solid tumor&#xD;
  &#xD;
            -  Diagnosis of advanced or locally advanced disease&#xD;
  &#xD;
            -  Patients candidated to receive standard therapy in the following line:&#xD;
  &#xD;
            -  first, second or third-line therapy for colon-rectal cancer in IV stage&#xD;
  &#xD;
            -  first or second-line therapy for gastric cancer in IV stage&#xD;
  &#xD;
            -  primary intent or first-line therapy for pancreatic cancer&#xD;
  &#xD;
            -  first-line therapy for bile duct cancer&#xD;
  &#xD;
            -  first or second-line therapy for hepatocarcinoma&#xD;
  &#xD;
            -  first, second, third, fourth or fifth-line therapy for breast cancer in IV stage&#xD;
  &#xD;
            -  chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of&#xD;
               first relapse&#xD;
  &#xD;
            -  first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)&#xD;
  &#xD;
            -  first or second-line therapy for advanced or locally advanced cervical cancer&#xD;
  &#xD;
            -  therapy for locally advanced or first line therapy for metastatic vulva cancer&#xD;
  &#xD;
            -  first, second or third-line therapy for melanoma (third-line therapy only in&#xD;
               BRAF-mutated melanoma)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of any secondary malignancy within the last 3 years, except for adequately&#xD;
               treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.&#xD;
  &#xD;
            -  Patients unable or unwilling to undergo as per protocol assessments at the four&#xD;
               planned timepoints&#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>Fabio Puglisi, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fabio Puglisi, MD, PhD</last_name>
      <phone>0434659253</phone>
      <email>fabio.puglisi@cro.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Giulia Cudia, MSc</last_name>
      <email>giulia.cudia@cro.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano</name>
        <address>
          <city>Aviano</city>
          <state>Pordonone</state>
          <zip>33081</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fabio Puglisi, MD, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Neoplasms</mesh_term>
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Bile Duct Neoplasms</mesh_term>
      <mesh_term>Cholangiocarcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
      <mesh_term>Vulvar Neoplasms</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/NCT06028724
  org study id: CRO-2022-51
  nct id: NCT06028724
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The implementation of liquid biopsy in clinical practice has been favored by the rapid
        development of genome sequencing techniques designed to analyze mutations in ctDNA. Among
        these, the Next generation sequencing (NGS) is a technique that consists in sequencing
        several genomes in a short time span, collecting information about a wider range of genomic
        alterations, using small quantities of genetic material. It is used to identify potential
        circulating dynamic biomarkers of treatment sensitivity or resistance in a real word
        multi-pathology evaluation. In this way, defining the mutational status of clinical relevance
        genes in real world, as a predictive biomarker to identify those patients most likely to
        benefit from target therapy, offers the potential to optimize access to further therapies.
        The aim of this study is to evaluate the real-world prevalence of clinically useful mutations
        in patients who are receiving therapy for advanced and locally advanced solid tumor through
        liquid biopsy.
  observational model: Cohort
  time perspective: Prospective
  measure: Real world prevalence of clinically useful mutations in solid tumors
  time frame: at the beginning of treatment
  description: Real world prevalence of clinically useful mutations in solid tumors, defined as the proportion of patients with the detection of clinically useful mutations through ctDNA NGS, at the beginning of systemic therapies defined as per inclusion criteria for advanced disease.
  measure: To identify emerging gene alterations associated with Progression Free Survival
  time frame: from study enrollment until progression or death for any cause, up to 7 years
  description: To identify emerging gene alterations associated with Progression Free Survival (PFS) defined as the time from study enrollment until progression or death for any cause, whichever comes first
  measure: To identify emerging gene alterations associated with Overall Survival
  time frame: from study enrollment until death for any cause, up to 7 years
  description: To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause
  measure: To describe changes in ctDNA associated biomarkers during treatment
  time frame: up to 7 years
  description: Difference in frequency of patients with ctDNA associated biomarkers at different time point during treatment (at baseline, at start of cycle 2, at first radiological evaluation, at relapse or end of follow-up)
  measure: To evaluate the association between somatic genetic alterations and the histopathological features of the tumor
  time frame: up to 7 years
  description: Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics
  measure: To evaluate the association between somatic genetic alterations and pattern of metastasis
  time frame: up to 7 years
  description: Frequency of somatic genetic alterations in subgroups of patients with metastasis
  measure: To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients
  time frame: up to 7 years
  description: Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fabio Puglisi, MD, PhD
  role: Principal Investigator
  affiliation: IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
  last name: Fabio Puglisi, MD, PhD
  phone: 0434659253
  email: fabio.puglisi@cro.it
  last name: Giulia Cudia, MSc
  email: giulia.cudia@cro.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Endometrial Neoplasms
  mesh term: Bile Duct Neoplasms
  mesh term: Cholangiocarcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Vulvar Neoplasms