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/NCT06016868</url>
    </required_header>
    <id_info>
      <org_study_id>5773</org_study_id>
      <nct_id>NCT06016868</nct_id>
    </id_info>
    <brief_title>Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients</brief_title>
    <acronym>MOLLY</acronym>
    <official_title>Identification of a MOLecuLar Signature Predicting Radiosensitivity in Locally Advanced Cervical Cancer Patients (LACC) Treated With Exclusive radiochemotherapY: 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>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 importance of radioresistance in cervical cancer treatment failure indicates that certain&#xD;
        biomarkers may be useful for cervical cancer treatment individualization. However, to date,&#xD;
        no study has analyzed the role of the gene expression signature of the three RNA species&#xD;
        (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients&#xD;
        undergoing exclusive CTRT. The previously validated three-gene signature may enable&#xD;
        stratification in LACC patients treated with the current standard of care, represented by&#xD;
        exclusive CTRT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The importance of radioresistance in cervical cancer treatment failure indicates that certain&#xD;
        biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers&#xD;
        of cervical cancer radioresistance have been previously studied and proposed; however, none&#xD;
        of these has been the subject to further clinical studies and implemented into clinical&#xD;
        practice. Recently, a panel of three protein coding genes (ANXA2-NDRG1-STAT1) differently&#xD;
        expressed in radiosensitive LACC patients compared with the radioresistant ones, has been&#xD;
        proposed by our institution. The population of LACC patients included in a previous study was&#xD;
        treated with neo-adjuvant CTRT followed by radical surgery. However, to date, no study has&#xD;
        analyzed the role of the gene expression signature of the three RNA species&#xD;
        (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients&#xD;
        undergoing exclusive CTRT. The previously validated three-gene signature may enable&#xD;
        stratification in LACC patients treated with the current standard of care, represented by&#xD;
        exclusive CTRT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>To test the performance of the molecular signature.</measure>
      <time_frame>60 months</time_frame>
      <description>To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Cervical Cancer</condition>
    <arm_group>
      <arm_group_label>Interventional</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Tumor tissue</intervention_name>
      <description>Each newly diagnosed patient with LACC who meets the inclusion criteria will undergo cervical cancer biopsy either during the outpatient clinical examination or during examination during anesthetic. Part of the biopsy will be sent for histopathological analysis, while the remaining tissue will be embedded in OCT compound and immediately frozen at -80°C prior to transfer to biobank for subsequent analysis.</description>
      <arm_group_label>Interventional</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>Every patient will undergo a peripheral venous blood sample which will be processed to analyze the presence of the proteins codified by three RNA species (ANXA2-NDRG1-STAT1). This blood sample will be performed before starting the treatment with exclusive CTRT.</description>
      <arm_group_label>Interventional</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with histologically-confirmed squamous cell carcinoma, adenocarcinoma, or&#xD;
          adenosquamous carcinoma of the cervix FIGO stage IIB and IIIC1.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years&#xD;
  &#xD;
            -  Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous&#xD;
               carcinoma of the cervix&#xD;
  &#xD;
            -  FIGO 2018 stage IIB and IIIC1[38]&#xD;
  &#xD;
            -  Treatment with exclusive chemoradiation including brachytherapy&#xD;
  &#xD;
            -  Has not previously received any definitive surgical, radiation, or systemic therapy&#xD;
               for cervical cancer&#xD;
  &#xD;
            -  Has radiographically evaluable disease, measurable per RECIST 1.1&#xD;
  &#xD;
            -  Negative pregnancy test&#xD;
  &#xD;
            -  Adequate hematologic, renal, and hepatic functions, with following blood tests:&#xD;
  &#xD;
          Neutrophils &gt; 1500/μL Platelets &gt; 100.000/ μL Hemoglobin &gt; 9 g/dL Serum creatinine &lt; 1.8&#xD;
          mg/dL Total bilirubin &lt; 3 mg/ dL LDH &lt; 3x normal value GOT &lt; 3x normal value GPT &lt; 3x&#xD;
          normal value ALP &lt; 3 x normal value&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid&#xD;
               etc)&#xD;
  &#xD;
            -  Neo-adjuvant treatment&#xD;
  &#xD;
            -  Patients included in other clinical trials&#xD;
  &#xD;
            -  Patients refusing to sign informed consent&#xD;
  &#xD;
            -  Contraindications to radiotherapy&#xD;
  &#xD;
            -  Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic&#xD;
               pelvic inflammatory disease, previous pelvic radiotherapy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gabriella Maria F Ferrandina, PhD</last_name>
      <phone>0630158667</phone>
      <email>mariagabriella.ferrandina@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Policlinico Universitario Agostino Gemelli, IRCCS</name>
        <address>
          <city>Rome</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Gabriella F Ferrandina, PhD</last_name>
        <phone>0630158667</phone>
        <email>mariagabriella.ferrandina@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>Uterine Cervical Neoplasms</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/NCT06016868
  org study id: 5773
  nct id: NCT06016868
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The importance of radioresistance in cervical cancer treatment failure indicates that certain
        biomarkers may be useful for cervical cancer treatment individualization. However, to date,
        no study has analyzed the role of the gene expression signature of the three RNA species
        (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients
        undergoing exclusive CTRT. The previously validated three-gene signature may enable
        stratification in LACC patients treated with the current standard of care, represented by
        exclusive CTRT.
  The importance of radioresistance in cervical cancer treatment failure indicates that certain
        biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers
        of cervical cancer radioresistance have been previously studied and proposed; however, none
        of these has been the subject to further clinical studies and implemented into clinical
        practice. Recently, a panel of three protein coding genes (ANXA2-NDRG1-STAT1) differently
        expressed in radiosensitive LACC patients compared with the radioresistant ones, has been
        proposed by our institution. The population of LACC patients included in a previous study was
        treated with neo-adjuvant CTRT followed by radical surgery. However, to date, no study has
        analyzed the role of the gene expression signature of the three RNA species
        (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients
        undergoing exclusive CTRT. The previously validated three-gene signature may enable
        stratification in LACC patients treated with the current standard of care, represented by
        exclusive CTRT.
  observational model: Cohort
  time perspective: Prospective
  measure: To test the performance of the molecular signature.
  time frame: 60 months
  description: To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.
  arm group label: Interventional
  intervention type: Procedure
  intervention name: Tumor tissue
  description: Each newly diagnosed patient with LACC who meets the inclusion criteria will undergo cervical cancer biopsy either during the outpatient clinical examination or during examination during anesthetic. Part of the biopsy will be sent for histopathological analysis, while the remaining tissue will be embedded in OCT compound and immediately frozen at -80°C prior to transfer to biobank for subsequent analysis.
  arm group label: Interventional
  intervention type: Procedure
  intervention name: Blood sample
  description: Every patient will undergo a peripheral venous blood sample which will be processed to analyze the presence of the proteins codified by three RNA species (ANXA2-NDRG1-STAT1). This blood sample will be performed before starting the treatment with exclusive CTRT.
  arm group label: Interventional
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gabriella Maria F Ferrandina, PhD
  phone: 0630158667
  email: mariagabriella.ferrandina@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: No