<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/NCT03809585</url>
  </required_header>
  <id_info>
    <org_study_id>6612-IRIS</org_study_id>
    <secondary_id>R01EY028755</secondary_id>
    <nct_id>NCT03809585</nct_id>
  </id_info>
  <brief_title>Observational Study of Iris Tumors</brief_title>
  <official_title>Observational Study of Iris Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</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>
      This is an observational study using OCT angiography to assist with tumor characterization in&#xD;
      melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be&#xD;
      compared to eyes with various types of iris tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor Thickness in Benign vs Malignant Iris Lesions</measure>
    <time_frame>6 months</time_frame>
    <description>OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor Area in Benign vs Malignant Iris Lesions</measure>
    <time_frame>6 months</time_frame>
    <description>Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor Volume in Benign vs Malignant Iris Lesions</measure>
    <time_frame>6 months</time_frame>
    <description>Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Iris Tumor</condition>
  <arm_group>
    <arm_group_label>Iris Tumors</arm_group_label>
    <description>This group will consist of 50 adults age 18 or older who have been diagnosed with either melanotic or amelanotic iris tumors. Iris tumor diagnosis will be confirmed by biopsy when possible or based upon clinical features (if patient declines biopsy or if not medically indicated) according to standard-of-care guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>This group will consist of 50 adults age 18 and older who have healthy eyes.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults age 18 or older with either healthy eyes or iris tumors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for tumor group:&#xD;
&#xD;
          -  Eyes with diagnosis of melanotic or amelanotic iris tumors&#xD;
&#xD;
        Inclusion Criteria for healthy control group:&#xD;
&#xD;
          -  Eyes without iris defects or lesions&#xD;
&#xD;
        Exclusion Criteria (both groups):&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Inability to maintain stable fixation for OCT imaging&#xD;
&#xD;
          -  Inability to commit to required study visits&#xD;
&#xD;
          -  Eyes with concurrent retinal diseases, glaucoma, or conditions that in the opinion of&#xD;
             the investigators might affect iris circulation&#xD;
&#xD;
          -  Mature cataracts if found to limit visual potential to worse than 20/40&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Huang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denzil Romfh, OD</last_name>
    <phone>503-494-4351</phone>
    <email>romfhd@ohsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Humberto Martinez, COT</last_name>
    <phone>503-494-7712</phone>
    <email>martinhu@ohsu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denzil Romfh, OD</last_name>
      <phone>503-494-4351</phone>
      <email>romfhd@ohsu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Humberto Martinez, COT</last_name>
      <phone>503-494-7712</phone>
      <email>martinhu@ohsu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>David Huang</investigator_full_name>
    <investigator_title>Peterson Professor of Ophthalmology &amp; Professor of Biomedical Engineering</investigator_title>
  </responsible_party>
  <keyword>Iris</keyword>
  <keyword>Tumor</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Optical Coherence Tomography (OCT)</keyword>
  <keyword>Angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iris Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03809585
org study id: 6612-IRIS
secondary id: R01EY028755
nct id: NCT03809585
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational study using OCT angiography to assist with tumor characterization in
      melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be
      compared to eyes with various types of iris tumors.
observational model: Case-Control
time perspective: Prospective
measure: Tumor Thickness in Benign vs Malignant Iris Lesions
time frame: 6 months
description: OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions.
measure: Tumor Area in Benign vs Malignant Iris Lesions
time frame: 6 months
description: Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.
measure: Tumor Volume in Benign vs Malignant Iris Lesions
time frame: 6 months
description: Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.
measure: Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures
time frame: 6 months after treatment
description: Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.
arm group label: Iris Tumors
description: This group will consist of 50 adults age 18 or older who have been diagnosed with either melanotic or amelanotic iris tumors. Iris tumor diagnosis will be confirmed by biopsy when possible or based upon clinical features (if patient declines biopsy or if not medically indicated) according to standard-of-care guidelines.
arm group label: Healthy Controls
description: This group will consist of 50 adults age 18 and older who have healthy eyes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Huang, MD, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Denzil Romfh, OD
phone: 503-494-4351
email: romfhd@ohsu.edu
last name: Humberto Martinez, COT
phone: 503-494-7712
email: martinhu@ohsu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: David Huang
investigator title: Peterson Professor of Ophthalmology & Professor of Biomedical Engineering
mesh term: Iris Neoplasms