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/NCT05993910</url>
    </required_header>
    <id_info>
      <org_study_id>HTRegister2014</org_study_id>
      <nct_id>NCT05993910</nct_id>
    </id_info>
    <brief_title>Prospective Hyperthermia Database in Cancer Patients (HT Register)</brief_title>
    <acronym>HTRegister</acronym>
    <official_title>Prospektive Hyperthermie-Datenbank Bei Krebspatienten (HTRegister)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pirus Ghadjar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Charite University, Berlin, Germany</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        This monocentric study registry records all cancer patients at the Charité which are treated&#xD;
        with hyperthermia to examine the therapeutic use of hyperthermia in cancer patients in the&#xD;
        general application and to obtain an accurate risk-benefit balance&#xD;
  &#xD;
        After confinement in this database are the patients prospectively in order to complications,&#xD;
        disease status and survival status tracked.&#xD;
  &#xD;
        Furthermore there is the possibility in the course of this study to an optional take part in&#xD;
        translational accompanying research with the aim of prognostic factors for response to&#xD;
        hyperthermia treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 1000 patients with various diseases with the indication for hyperthermia in&#xD;
        addition to standard oncological therapy (radiation therapy, chemotherapy, radiochemotherapy)&#xD;
        will be included in this registry protocol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2014</start_date>
    <completion_date type="Anticipated">October 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2028</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>10 Years</target_duration>
    <primary_outcome>
      <measure>Effectivity</measure>
      <time_frame>Through the study completion, up to 10 years</time_frame>
      <description>To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Toxicity</measure>
      <time_frame>Through the study completion, up to 10 years</time_frame>
      <description>Toxicity assessment based on Common Toxicity Criteria Scoring</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Hyperthermia</condition>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Hyperthermie Register</arm_group_label>
      <description>Hyperthermia simultaneous with Radiotherapy alone, Hyperthermia simultaneous with Chemotherapy alone, Hyperthermia simultaneous with Radiochemotherapy alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hyperthermie Register</intervention_name>
      <description>die Höhe der Temperatur im Zielgebiet (42,5 bis 43 °C),&#xD;
  die Dauer der Anwendung und&#xD;
  die simultane Therapie mit Chemo- und/oder Strahlentherapie</description>
      <arm_group_label>Hyperthermie Register</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood and tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          It is planned to include the first 1.000 patients in this prospective database. Because of&#xD;
          the characters in the database is a certain gender distribution not laid down . Confinement&#xD;
          are capable of all patients in the Charité , which has a hyperthermia treatment ,&#xD;
          regardless of age or gender&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Contrazeption with female patients at the capable of bearing children age&#xD;
  &#xD;
            -  Written agreement is present (DvH, ICH-GCP)&#xD;
  &#xD;
            -  Patients, who participate at the same time in a interventional study, can nevertheless&#xD;
               in this register study participate if this none Exclusion criterion for the&#xD;
               interventional study represents.&#xD;
  &#xD;
            -  With children must the treatment with one of the GPOH agreed Pattern take place&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria for the hyperthermia (such as hip prosthesis in the therapeutic&#xD;
               area, metal implants/marker, patients with cardiac pacemakers)&#xD;
  &#xD;
            -  mental disease, what the proper study participation does not allow.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pirus Ghadjar, PD Dr.</last_name>
      <phone>+4930450657055</phone>
      <email>pirus.ghadjar@charite.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinic for Radio - Oncology and Radiotherapy</name>
        <address>
          <city>Berlin</city>
          <zip>13353</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Pirus Ghadjar, Prof Dr.</last_name>
        <phone>+4930450657055</phone>
        <email>pirus.ghadjar@charite.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinic for Radio - Oncology and Radiotherapy</name>
        <address>
          <city>Berlin</city>
          <zip>13353</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pirus Ghadjar, Prof. Dr.</last_name>
        <phone>+4930450657055</phone>
        <email>pirus.ghadjar@charite.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
      <investigator_full_name>Pirus Ghadjar</investigator_full_name>
      <investigator_title>Prof. Dr. med.</investigator_title>
    </responsible_party>
    <keyword>Hyperthermia E02.565</keyword>
    <keyword>HTRegister</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperthermia</mesh_term>
      <mesh_term>Fever</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT05993910
  org study id: HTRegister2014
  nct id: NCT05993910
  lead sponsor: 
  has dmc: No
  This monocentric study registry records all cancer patients at the Charité which are treated
        with hyperthermia to examine the therapeutic use of hyperthermia in cancer patients in the
        general application and to obtain an accurate risk-benefit balance
  
        After confinement in this database are the patients prospectively in order to complications,
        disease status and survival status tracked.
  
        Furthermore there is the possibility in the course of this study to an optional take part in
        translational accompanying research with the aim of prognostic factors for response to
        hyperthermia treatment.
  A total of 1000 patients with various diseases with the indication for hyperthermia in
        addition to standard oncological therapy (radiation therapy, chemotherapy, radiochemotherapy)
        will be included in this registry protocol.
  observational model: Other
  time perspective: Prospective
  measure: Effectivity
  time frame: Through the study completion, up to 10 years
  description: To determine the effectiveness of hyperthermia treatment, patients are tracked in terms of overall survival , progression-free survival and disease-free survival
  measure: Toxicity
  time frame: Through the study completion, up to 10 years
  description: Toxicity assessment based on Common Toxicity Criteria Scoring
  arm group label: Hyperthermie Register
  description: Hyperthermia simultaneous with Radiotherapy alone, Hyperthermia simultaneous with Chemotherapy alone, Hyperthermia simultaneous with Radiochemotherapy alone
  intervention type: Other
  intervention name: Hyperthermie Register
  description: die Höhe der Temperatur im Zielgebiet (42,5 bis 43 °C),
  die Dauer der Anwendung und
  die simultane Therapie mit Chemo- und/oder Strahlentherapie
  arm group label: Hyperthermie Register
  Blood and tissue
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Pirus Ghadjar, PD Dr.
  phone: +4930450657055
  email: pirus.ghadjar@charite.de
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Sponsor-Investigator
  investigator affiliation: Charite University, Berlin, Germany
  investigator full name: Pirus Ghadjar
  investigator title: Prof. Dr. med.
  mesh term: Hyperthermia
  mesh term: Fever
  sharing ipd: Yes