<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/NCT04458935</url>
  </required_header>
  <id_info>
    <org_study_id>999920129</org_study_id>
    <secondary_id>20-EI-N129</secondary_id>
    <nct_id>NCT04458935</nct_id>
  </id_info>
  <brief_title>Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma</brief_title>
  <official_title>Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      Retinal hemangioblastoma (RH) is a tumor. It grows from the retina in the eye. It can&#xD;
      threaten a person s vision. Trans-scleral cryotherapy is used to destroy the tumors and&#xD;
      minimize the long-term risks of vision loss. RH is a rare condition, often occurring in&#xD;
      people with von Hippel-Lindau disease. There are no clinical trials to study how well the&#xD;
      treatment works. Researchers want to study the medical records of people with RH who were&#xD;
      treated at the NIH eye clinic to learn more.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To analyze clinical data collected over a 20-year span to study consecutive cases of RH&#xD;
      managed with trans-scleral cryotherapy at the NIH.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People who took part in NIH natural history protocols for which cryotherapy of RH was&#xD;
      performed as a standard care measure.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Researchers will collect and study data from participants medical charts. Participants will&#xD;
      not be contacted because no new data is needed. Researchers were granted a waiver of informed&#xD;
      consent for use of these medical records. To protect patient privacy, participants will be&#xD;
      assigned an ID number. Their data will be entered into a spreadsheet in a coded fashion. The&#xD;
      key to this code will be kept in a secure file. No patient identifying information will be&#xD;
      used in the analysis or the publication....&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Description: This study is a retrospective review of medical records in the NIH eye&#xD;
      clinic. To our knowledge, there has been no report in the current era dedicated to a&#xD;
      description of trans-scleral cryotherapy for retinal hemangioblastomas despite its routine&#xD;
      use in this setting. This study aims to explore features and outcomes of these cases to&#xD;
      better inform best practices.&#xD;
&#xD;
      Objectives: The objective of this study is to perform a retrospective analysis of consecutive&#xD;
      cases of retinal hemangioblastoma managed with trans-scleral cryotherapy at the NIH (single&#xD;
      center retrospective case series).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Data analysis</measure>
    <time_frame>ongoing</time_frame>
    <description>Analysis of previously collected data from participants with RH managed with Trans-scleral cryotherapy.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Retinal Hemangioblastoma</condition>
  <condition>Von Hippel-Lindau Disease</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <description>Participants with retinal hemangioblastoma (RH) managed with trans-scleral cryotherapy at the NIH.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Data (medical history and images) was collected under NEI and non-NEI natural history&#xD;
        protocols allowing administration of standard care measures to participants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Participants were enrolled in NEI and non-NEI natural history protocols, but in&#xD;
                  all cases, cryotherapy was administered as a standard care measure (not as an&#xD;
                  investigative treatment).&#xD;
&#xD;
               2. Patients were identified by searching the NIH eye clinic EMR for all of those&#xD;
                  manifesting one or more retinal hemangioblastomas (with or without associated von&#xD;
                  Hippel-Lindau disease) treated with cryotherapy.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Y Chew, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Eye Institute (NEI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Eye Institute (NEI)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 15, 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular Tumor</keyword>
  <keyword>Vision Loss</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioblastoma</mesh_term>
    <mesh_term>Von Hippel-Lindau Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04458935
org study id: 999920129
secondary id: 20-EI-N129
nct id: NCT04458935
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Retinal hemangioblastoma (RH) is a tumor. It grows from the retina in the eye. It can
      threaten a person s vision. Trans-scleral cryotherapy is used to destroy the tumors and
      minimize the long-term risks of vision loss. RH is a rare condition, often occurring in
      people with von Hippel-Lindau disease. There are no clinical trials to study how well the
      treatment works. Researchers want to study the medical records of people with RH who were
      treated at the NIH eye clinic to learn more.

      Objective:

      To analyze clinical data collected over a 20-year span to study consecutive cases of RH
      managed with trans-scleral cryotherapy at the NIH.

      Eligibility:

      People who took part in NIH natural history protocols for which cryotherapy of RH was
      performed as a standard care measure.

      Design:

      Researchers will collect and study data from participants medical charts. Participants will
      not be contacted because no new data is needed. Researchers were granted a waiver of informed
      consent for use of these medical records. To protect patient privacy, participants will be
      assigned an ID number. Their data will be entered into a spreadsheet in a coded fashion. The
      key to this code will be kept in a secure file. No patient identifying information will be
      used in the analysis or the publication....
Study Description: This study is a retrospective review of medical records in the NIH eye
      clinic. To our knowledge, there has been no report in the current era dedicated to a
      description of trans-scleral cryotherapy for retinal hemangioblastomas despite its routine
      use in this setting. This study aims to explore features and outcomes of these cases to
      better inform best practices.

      Objectives: The objective of this study is to perform a retrospective analysis of consecutive
      cases of retinal hemangioblastoma managed with trans-scleral cryotherapy at the NIH (single
      center retrospective case series).
observational model: Cohort
time perspective: Other
measure: Data analysis
time frame: ongoing
description: Analysis of previously collected data from participants with RH managed with Trans-scleral cryotherapy.
arm group label: Participants
description: Participants with retinal hemangioblastoma (RH) managed with trans-scleral cryotherapy at the NIH.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Emily Y Chew, M.D.
role: Principal Investigator
affiliation: National Eye Institute (NEI)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hemangioblastoma
mesh term: Von Hippel-Lindau Disease
sharing ipd: No