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/NCT05964153</url>
    </required_header>
    <id_info>
      <org_study_id>I3PT_SG2022_01</org_study_id>
      <nct_id>NCT05964153</nct_id>
    </id_info>
    <brief_title>Analysis of Circulating DNA in Blood Samples of Glioma-affected Patients</brief_title>
    <official_title>Pilot Study of Liquid Biopsy as a Diagnostic Tool for Gliomas by Analyzing Circulating Tumor DNA in Blood Samples, and Its Validation With the Corresponding Tissue Biopsies.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Corporacion Parc Tauli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Corporacion Parc Tauli</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 present pilot study aims to investigate a new strategy in the liquid biopsy protocol for&#xD;
        the diagnosis of gliomas based on the detection of circulating tumor DNA in the blood of&#xD;
        patients with brain lesions compatible with this type of tumor.&#xD;
  &#xD;
        In order to increase the sensitivity of the technique, the investigators will work with raw&#xD;
        blood samples through minimally invasive procedures. The subsequent analysis will be done&#xD;
        with digital PCR, due to its low detection limit. The mutational results of each patient's&#xD;
        samples will be compared with those obtained from the corresponding tissue biopsies. This&#xD;
        step will allow the team to determine the robustness and reliability of the liquid biopsy.&#xD;
        The grading of the tumor, as well as the confirmation of the diagnosis, will be obtained from&#xD;
        the histological data.&#xD;
  &#xD;
        With the inclusion of more patients in the future, and with the optimization of the mutations&#xD;
        investigated, the investigators want to standardize the protocol for the diagnosis of gliomas&#xD;
        with liquid biopsy. This technique is less invasive than current surgical procedures used for&#xD;
        diagnosis. In addition, using fewer hospital resources should allow a more accurate and rapid&#xD;
        diagnosis of the pathology, and therefore, start the more personalized therapeutic stage&#xD;
        earlier.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Currently, brain tumors are detected by means of an imaging technique (usually magnetic&#xD;
        resonance imaging) with a contrast agent. The determination of the type of tumor, as well as&#xD;
        its grading, is usually done subsequently with a biopsy of the tissue, where different solid&#xD;
        samples are extracted as representative as possible to analyze them in the Pathological&#xD;
        Anatomy service. Nevertheless, there are some factors that limit surgical access, such as:&#xD;
        the advanced age of the patient, the location of the tumor in eloquent or risky areas, as&#xD;
        well as the presence of large tumors with very diffuse borders. In these cases, the diagnosis&#xD;
        of the brain tumor is usually made directly with the magnetic resonance image, which implies&#xD;
        a risk of error due to the lack of clinical information from this test.&#xD;
  &#xD;
        Limitations like these make the minimally invasive procedure of liquid biopsy an extremely&#xD;
        necessary diagnostic tool. For this reason, the investigators want to start a pilot study of&#xD;
        this technique in those patients with brain lesions in the resonance images compatible with a&#xD;
        glioma-like tumor.&#xD;
  &#xD;
        In particular, the main aim of the study is to analyze the blood samples obtained from these&#xD;
        patients in order to detect and quantify the circulating DNA (ctDNA) of tumor cells on it.&#xD;
        These DNA fragments are expelled into the bloodstream by mechanisms still unknown as a result&#xD;
        of numerous processes of apoptosis and necrosis of tumor cells. By analyzing them through a&#xD;
        ddPCR, the investigators will try to detect the specific mutations present in this tumoral&#xD;
        ctDNA, allowing the team to confirm the presence of a glioma-type tumor, and providing&#xD;
        real-time information of its classification as astrocytoma or oligodendroglioma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 31, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Actual">July 31, 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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Circulating free DNA detection</measure>
      <time_frame>1 year (2023-2024)</time_frame>
      <description>Circulating free DNA detection in blood samples of patients by means of a ddPCR</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Glioma</condition>
    <condition>Circulating Tumor Cell</condition>
    <arm_group>
      <arm_group_label>Circulating free DNA analysis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Correlate the results of the tissue samples with those of the blood samples, the concentration of ctDNA found, and the magnetic resonance images prior to the biopsies.&#xD;
  Compare other variables such as time, money, and the impact on the patient (recovery time after biopsies, pain, sequelae,...) between the liquid biopsy procedure and the conventional tissue biopsy procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Liquid Biopsy</intervention_name>
      <description>Analysis of the circulating free DNA in blood patients affected by gliomas</description>
      <arm_group_label>Circulating free DNA analysis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years.&#xD;
  &#xD;
            -  De novo primary brain lesion, compatible with a glioma according to contrast-enhanced&#xD;
               magnetic resonance images. The injury must be treated by the usual surgical procedure.&#xD;
  &#xD;
            -  Signature of informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breastfeeding women.&#xD;
  &#xD;
            -  Reasonable doubts in the diagnosis of glioma by magnetic resonance, or patients whose&#xD;
               tissue biopsy diagnoses a brain lesion other than a glioma.&#xD;
  &#xD;
            -  Patients who cannot undergo surgical resection, or when the tissue samples taken are&#xD;
               not significant enough to be analyzed.&#xD;
  &#xD;
            -  Inability or disagreement with signing the informed consent.&#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>Silvia Gil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Universitari Parc Taulí</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Coloma Moreno</last_name>
      <phone>+34937231010</phone>
      <email>cmoreno@tauli.cat</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Universitari Parc Taulí</name>
        <address>
          <city>Sabadell</city>
          <state>Barcelona</state>
          <zip>08208</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvia Gil, PhD</last_name>
        <phone>+34937231010</phone>
        <email>sgil@tauli.cat</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
      <investigator_full_name>Silvia Gil-Duran</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Liquid Biopsy</keyword>
    <keyword>Glioma</keyword>
    <keyword>Circulating free DNA</keyword>
    <keyword>ddPCR</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioma</mesh_term>
      <mesh_term>Neoplastic Cells, Circulating</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/NCT05964153
  org study id: I3PT_SG2022_01
  nct id: NCT05964153
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The present pilot study aims to investigate a new strategy in the liquid biopsy protocol for
        the diagnosis of gliomas based on the detection of circulating tumor DNA in the blood of
        patients with brain lesions compatible with this type of tumor.
  
        In order to increase the sensitivity of the technique, the investigators will work with raw
        blood samples through minimally invasive procedures. The subsequent analysis will be done
        with digital PCR, due to its low detection limit. The mutational results of each patient's
        samples will be compared with those obtained from the corresponding tissue biopsies. This
        step will allow the team to determine the robustness and reliability of the liquid biopsy.
        The grading of the tumor, as well as the confirmation of the diagnosis, will be obtained from
        the histological data.
  
        With the inclusion of more patients in the future, and with the optimization of the mutations
        investigated, the investigators want to standardize the protocol for the diagnosis of gliomas
        with liquid biopsy. This technique is less invasive than current surgical procedures used for
        diagnosis. In addition, using fewer hospital resources should allow a more accurate and rapid
        diagnosis of the pathology, and therefore, start the more personalized therapeutic stage
        earlier.
  Currently, brain tumors are detected by means of an imaging technique (usually magnetic
        resonance imaging) with a contrast agent. The determination of the type of tumor, as well as
        its grading, is usually done subsequently with a biopsy of the tissue, where different solid
        samples are extracted as representative as possible to analyze them in the Pathological
        Anatomy service. Nevertheless, there are some factors that limit surgical access, such as:
        the advanced age of the patient, the location of the tumor in eloquent or risky areas, as
        well as the presence of large tumors with very diffuse borders. In these cases, the diagnosis
        of the brain tumor is usually made directly with the magnetic resonance image, which implies
        a risk of error due to the lack of clinical information from this test.
  
        Limitations like these make the minimally invasive procedure of liquid biopsy an extremely
        necessary diagnostic tool. For this reason, the investigators want to start a pilot study of
        this technique in those patients with brain lesions in the resonance images compatible with a
        glioma-like tumor.
  
        In particular, the main aim of the study is to analyze the blood samples obtained from these
        patients in order to detect and quantify the circulating DNA (ctDNA) of tumor cells on it.
        These DNA fragments are expelled into the bloodstream by mechanisms still unknown as a result
        of numerous processes of apoptosis and necrosis of tumor cells. By analyzing them through a
        ddPCR, the investigators will try to detect the specific mutations present in this tumoral
        ctDNA, allowing the team to confirm the presence of a glioma-type tumor, and providing
        real-time information of its classification as astrocytoma or oligodendroglioma.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Circulating free DNA detection
  time frame: 1 year (2023-2024)
  description: Circulating free DNA detection in blood samples of patients by means of a ddPCR
  arm group label: Circulating free DNA analysis
  arm group type: Experimental
  description: Correlate the results of the tissue samples with those of the blood samples, the concentration of ctDNA found, and the magnetic resonance images prior to the biopsies.
  Compare other variables such as time, money, and the impact on the patient (recovery time after biopsies, pain, sequelae,...) between the liquid biopsy procedure and the conventional tissue biopsy procedure.
  intervention type: Diagnostic Test
  intervention name: Liquid Biopsy
  description: Analysis of the circulating free DNA in blood patients affected by gliomas
  arm group label: Circulating free DNA analysis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Silvia Gil
  role: Principal Investigator
  affiliation: Hospital Universitari Parc Taulí
  last name: Coloma Moreno
  phone: +34937231010
  email: cmoreno@tauli.cat
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Corporacion Parc Tauli
  investigator full name: Silvia Gil-Duran
  investigator title: Principal Investigator
  mesh term: Glioma
  mesh term: Neoplastic Cells, Circulating
  sharing ipd: No