<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/NCT03267381</url>
  </required_header>
  <id_info>
    <org_study_id>VICC MEL 1783</org_study_id>
    <nct_id>NCT03267381</nct_id>
  </id_info>
  <brief_title>Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy</brief_title>
  <official_title>Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt-Ingram Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wren Laboratories LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt-Ingram Cancer Center</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>
      To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated&#xD;
      from the peripheral blood of patients with melanoma, to identify active disease, provide an&#xD;
      assessment of treatment responses, or predict risk of relapse, in conjunction with standard&#xD;
      clinical assessment and imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Evaluate the diagnostic efficacy of a circulating melanoma gene signature in&#xD;
           pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node&#xD;
           positive) and compare this to LDH as a biomarker.&#xD;
&#xD;
        -  Evaluate the diagnostic efficacy of a circulating melanoma gene signature in&#xD;
           pathologically verified Stage IV melanoma (including pre-surgery patients as well as&#xD;
           those on either targeted or immunotherapy) and compare this to LDH as a biomarker.&#xD;
&#xD;
        -  Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and&#xD;
           IV tumors.&#xD;
&#xD;
        -  Monitor molecular signature levels in blood to assess efficacy of this tool as compared&#xD;
           to imaging or other biomarkers to define disease progression or treatment responses in&#xD;
           Stage III and IV treated patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</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>Efficacy (stage III)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assay Metrics</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Molecular signature levels</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy (Stage IV)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Arm 1a</arm_group_label>
    <description>Stage III melanoma diagnosis (biopsy-proven lymph node positive (this is either clinically palpable or enlarged nodes detected by imaging, which are then biopsied and have macroscopic disease).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 1b</arm_group_label>
    <description>Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <description>Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw (before surgery)</intervention_name>
    <description>Blood will be drawn before surgery</description>
    <arm_group_label>Arm 1a</arm_group_label>
    <arm_group_label>Arm 1b</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw (every 3 months)</intervention_name>
    <description>Blood will be drawn every 3 months</description>
    <arm_group_label>Arm 1a</arm_group_label>
    <arm_group_label>Arm 1b</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw (at diagnosis)</intervention_name>
    <description>Blood will be drawn at time of diagnosis</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with a diagnosis of stage III or IV melanoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Primary melanoma &gt; 1 mm in Breslow depth&#xD;
&#xD;
          3. Stage III or IV disease as determined either by sentinel node biopsy, biopsy of&#xD;
             clinically enlarged lymph nodes, and/or imaging. If stage IV, must have tissue biopsy&#xD;
             confirming presence of stage IV melanoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant patients&#xD;
&#xD;
          2. Contraindication to contrasted imaging (due to allergy or renal insufficiency)&#xD;
&#xD;
          3. Serum PCV &lt;30%&#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_official>
    <last_name>Rondi Kauffmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>vanderbilt Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Rondi Kauffmann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</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/NCT03267381
org study id: VICC MEL 1783
nct id: NCT03267381
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated
      from the peripheral blood of patients with melanoma, to identify active disease, provide an
      assessment of treatment responses, or predict risk of relapse, in conjunction with standard
      clinical assessment and imaging.
-  Evaluate the diagnostic efficacy of a circulating melanoma gene signature in
           pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node
           positive) and compare this to LDH as a biomarker.

        -  Evaluate the diagnostic efficacy of a circulating melanoma gene signature in
           pathologically verified Stage IV melanoma (including pre-surgery patients as well as
           those on either targeted or immunotherapy) and compare this to LDH as a biomarker.

        -  Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and
           IV tumors.

        -  Monitor molecular signature levels in blood to assess efficacy of this tool as compared
           to imaging or other biomarkers to define disease progression or treatment responses in
           Stage III and IV treated patients.
observational model: Case-Control
time perspective: Prospective
measure: Efficacy (stage III)
time frame: Up to 24 months
description: Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker.
measure: Assay Metrics
time frame: Up to 24 months
description: Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
measure: Molecular signature levels
time frame: Up to 24 months
description: Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.
measure: Efficacy (Stage IV)
time frame: Up to 24 months
description: Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker
arm group label: Arm 1a
description: Stage III melanoma diagnosis (biopsy-proven lymph node positive (this is either clinically palpable or enlarged nodes detected by imaging, which are then biopsied and have macroscopic disease).
arm group label: Arm 1b
description: Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).
arm group label: Arm 2
description: Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none
intervention type: Other
intervention name: Blood draw (before surgery)
description: Blood will be drawn before surgery
arm group label: Arm 1a
arm group label: Arm 1b
arm group label: Arm 2
intervention type: Other
intervention name: Blood draw (every 3 months)
description: Blood will be drawn every 3 months
arm group label: Arm 1a
arm group label: Arm 1b
intervention type: Other
intervention name: Blood draw (at diagnosis)
description: Blood will be drawn at time of diagnosis
arm group label: Arm 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rondi Kauffmann, MD
role: Principal Investigator
affiliation: vanderbilt Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Rondi Kauffmann
investigator title: Principal Investigator
mesh term: Recurrence