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/NCT05967143</url>
    </required_header>
    <id_info>
      <org_study_id>STX2501</org_study_id>
      <nct_id>NCT05967143</nct_id>
    </id_info>
    <brief_title>Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)</brief_title>
    <acronym>SIRtain</acronym>
    <official_title>Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sirtex Medical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sirtex Medical</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This registry seeks to prospectively gather a large repository of comprehensive observational&#xD;
        data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or&#xD;
        unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order&#xD;
        to assess clinical response in a real-world setting and further validate the safe and&#xD;
        appropriate use of SIR-Spheres&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a global, multi-center, prospective, observational cohort study (registry) to assess&#xD;
        real-world outcomes in patients with unresectable HCC or unresectable liver metastases from&#xD;
        mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with&#xD;
        SIR-Spheres per medical decision.&#xD;
  &#xD;
        The study will be conducted through the involvement of approximately 845 patients from up to&#xD;
        44 sites in an estimated 10 countries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">June 2029</completion_date>
    <primary_completion_date type="Anticipated">June 2028</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>24months from LPI</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Liver PFS (LPFS)</measure>
      <time_frame>24months from LPI</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>24months from LPI</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective response rate (ORR) and liver response rate (LRR)</measure>
      <time_frame>24months from LPI</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of response (DoR)</measure>
      <time_frame>24months from LPI</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change scores from baseline to follow-up timepoints of the EQ-5D-5L</measure>
      <time_frame>24months from LPI</time_frame>
      <description>The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30)</measure>
      <time_frame>24months from LPI</time_frame>
      <description>The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18)</measure>
      <time_frame>24months from LPI</time_frame>
      <description>The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SAEs/SADE's rates</measure>
      <time_frame>24months from LPI</time_frame>
      <description>Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subsequent hepatic procedures summarized at follow-up timepoints</measure>
      <time_frame>24months from LPI</time_frame>
      <description>Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare Resource Utilization summarized at follow-up timepoints</measure>
      <time_frame>24months from LPI</time_frame>
      <description>The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">845</enrollment>
    <condition>Unresectable Hepatocellular Carcinoma (HCC)</condition>
    <condition>Liver Metastases From Colorectal Cancer (mCRC)</condition>
    <arm_group>
      <arm_group_label>Patients with unresectable HCC or unresectable liver metastases from mCRC</arm_group_label>
      <description>This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SIRT</intervention_name>
      <description>Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.</description>
      <arm_group_label>Patients with unresectable HCC or unresectable liver metastases from mCRC</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a&#xD;
          Primary Care Clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Confirmed diagnosis of:&#xD;
  &#xD;
            -  Unresectable hepatocellular carcinoma (HCC) Or&#xD;
  &#xD;
            -  Unresectable liver metastases from colorectal cancer (mCRC) refractory to or&#xD;
               intolerant to chemotherapy&#xD;
  &#xD;
            -  Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the&#xD;
               normal course of practice&#xD;
  &#xD;
            -  Planned to receive SIR-Spheres treatment to the liver for the first time&#xD;
  &#xD;
            -  Provision of signed patient informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior radiation treatment to the liver&#xD;
  &#xD;
          Caveat:&#xD;
  &#xD;
          Sequential selective internal radiation therapy (SIRT) treatment is allowed&#xD;
  &#xD;
            -  Patients participating in any interventional clinical trial with an investigational&#xD;
               product, device, or procedure&#xD;
  &#xD;
            -  Need for surrogate consent. Patients who are not able to consent on behalf of&#xD;
               themselves are not eligible.&#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>Janet Bell</last_name>
      <phone>781-721-3840</phone>
      <email>jbell@sirtex.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital Beaujon</name>
        <address>
          <city>Clichy</city>
          <state>Cedex</state>
          <zip>92118</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Mohamed Bouattour</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hopital Henri Mondor</name>
        <address>
          <city>Créteil</city>
          <state>Paris</state>
          <zip>94000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Hélène Regnault</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud</name>
        <address>
          <city>Pierre-Bénite</city>
          <state>Rhône</state>
          <zip>69495</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Nicolas Jacquet-Francillon</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Puerta de Hierro - Majadahonda</name>
        <address>
          <city>Majadahonda</city>
          <state>Madrid</state>
          <zip>28220</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Lourdes Gutierrez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital General Universitario Gregorio Marañon</name>
        <address>
          <city>Madrid</city>
          <zip>28009</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Pilar Garcia Alfonso</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Clinico Universitario de Valencia</name>
        <address>
          <city>Valencia</city>
          <zip>46010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Paloma Lluch</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Christie Hospital</name>
        <address>
          <city>Manchester</city>
          <state>Lancashire</state>
          <zip>M20 4BX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Saifee Mullamitha</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kings College Hospital</name>
        <address>
          <city>London</city>
          <zip>SE5 9RS</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Paul Ross</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hammersmith Hospital</name>
        <address>
          <city>London</city>
          <zip>W12 OHS</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Rohini Sharma</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
      <country>Spain</country>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Liver metastases from colorectal cancer (mCRC)</keyword>
    <keyword>Unresectable Hepatocellular carcinoma (HCC)</keyword>
    <keyword>SIR-Spheres microspheres</keyword>
    <keyword>Y-90 resin microspheres</keyword>
    <keyword>SIRT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</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/NCT05967143
  org study id: STX2501
  nct id: NCT05967143
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This registry seeks to prospectively gather a large repository of comprehensive observational
        data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or
        unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order
        to assess clinical response in a real-world setting and further validate the safe and
        appropriate use of SIR-Spheres
  This is a global, multi-center, prospective, observational cohort study (registry) to assess
        real-world outcomes in patients with unresectable HCC or unresectable liver metastases from
        mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with
        SIR-Spheres per medical decision.
  
        The study will be conducted through the involvement of approximately 845 patients from up to
        44 sites in an estimated 10 countries.
  observational model: Cohort
  time perspective: Prospective
  measure: Progression-free survival (PFS)
  time frame: 24months from LPI
  measure: Liver PFS (LPFS)
  time frame: 24months from LPI
  measure: Overall survival (OS)
  time frame: 24months from LPI
  measure: Objective response rate (ORR) and liver response rate (LRR)
  time frame: 24months from LPI
  measure: Duration of response (DoR)
  time frame: 24months from LPI
  measure: Change scores from baseline to follow-up timepoints of the EQ-5D-5L
  time frame: 24months from LPI
  description: The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.
  measure: Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30)
  time frame: 24months from LPI
  description: The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.
  measure: Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18)
  time frame: 24months from LPI
  description: The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').
  measure: SAEs/SADE's rates
  time frame: 24months from LPI
  description: Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates
  measure: Subsequent hepatic procedures summarized at follow-up timepoints
  time frame: 24months from LPI
  description: Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints
  measure: Healthcare Resource Utilization summarized at follow-up timepoints
  time frame: 24months from LPI
  description: The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.
  arm group label: Patients with unresectable HCC or unresectable liver metastases from mCRC
  description: This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision.
  intervention type: Device
  intervention name: SIRT
  description: Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
  arm group label: Patients with unresectable HCC or unresectable liver metastases from mCRC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Janet Bell
  phone: 781-721-3840
  email: jbell@sirtex.com
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  country: France
  country: Spain
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Neoplasm Metastasis
  mesh term: Carcinoma, Hepatocellular