<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/NCT02251314</url>
  </required_header>
  <id_info>
    <org_study_id>14-7467</org_study_id>
    <nct_id>NCT02251314</nct_id>
  </id_info>
  <brief_title>Use of Exome Sequence Analysis and Circulating Tumour in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma</brief_title>
  <official_title>The Utility and Relevance of Exome Sequence Analysis and Circulating Tumour DNA in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite recent advances in cancer treatment, little impact has been made on curing as opposed&#xD;
      to controlling cancers over the last several decades. Part of the problem is that&#xD;
      investigators have an incomplete understanding of how tumours behave as they evolve and in&#xD;
      response to treatment. In this trial, the investigators hope to better understand the&#xD;
      evolution of BRAF melanoma in response to drugs a patient may have received such as&#xD;
      vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours&#xD;
      evolve resistance to these drugs and whether this can be predicted through blood tests, in&#xD;
      particular of the circulating tumour DNA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study population: BRAF mutant melanoma patients&#xD;
&#xD;
      Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days&#xD;
      apart from each other, with the first blood draw taking place on the patient's first clinic&#xD;
      visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of&#xD;
      blood) will be taken from the patient.&#xD;
&#xD;
      When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation&#xD;
      Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or&#xD;
      family/substitute decision maker to ensure that they are still in agreement. The patient and&#xD;
      the families will also be provided with an additional consent form for participation&#xD;
      including blood sampling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">April 22, 2018</completion_date>
  <primary_completion_date type="Actual">January 2015</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>3 Years</target_duration>
  <primary_outcome>
    <measure>Percentage correlation between circulating tumour DNA and metastatic sites</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to death</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Melanoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Pre-mortem bloods taken to obtain ctDNA&#xD;
&#xD;
        -  Post-mortem bloods and tissue To understand to what extent circulating DNA (found in&#xD;
           Blood) represents the genetic content of underlying tumour metastases in BRAF mutant&#xD;
           melanoma, and&#xD;
&#xD;
        -  To correlate the appearance of metastasis-specific mutations in the ctDNA with&#xD;
           histological features in the tumours such as degree of necrosis, inflammation,&#xD;
           microvascular density, and location or size of primary tumour and metastases&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        UHN patients with BRAF mutant melanoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        UHN adult patient with BRAF mutant melanoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient&#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>Anthony Joshua, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BRAF mutant melanoma</keyword>
  <keyword>circulation tumour DNA</keyword>
  <keyword>tumour heterogeneity</keyword>
  <keyword>liquid biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</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/NCT02251314
org study id: 14-7467
nct id: NCT02251314
lead sponsor: 
has dmc: Yes
Despite recent advances in cancer treatment, little impact has been made on curing as opposed
      to controlling cancers over the last several decades. Part of the problem is that
      investigators have an incomplete understanding of how tumours behave as they evolve and in
      response to treatment. In this trial, the investigators hope to better understand the
      evolution of BRAF melanoma in response to drugs a patient may have received such as
      vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours
      evolve resistance to these drugs and whether this can be predicted through blood tests, in
      particular of the circulating tumour DNA.
Study population: BRAF mutant melanoma patients

      Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days
      apart from each other, with the first blood draw taking place on the patient's first clinic
      visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of
      blood) will be taken from the patient.

      When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation
      Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or
      family/substitute decision maker to ensure that they are still in agreement. The patient and
      the families will also be provided with an additional consent form for participation
      including blood sampling.
observational model: Other
time perspective: Prospective
measure: Percentage correlation between circulating tumour DNA and metastatic sites
time frame: 3 years
measure: Time to death
time frame: 2 years
-  Pre-mortem bloods taken to obtain ctDNA

        -  Post-mortem bloods and tissue To understand to what extent circulating DNA (found in
           Blood) represents the genetic content of underlying tumour metastases in BRAF mutant
           melanoma, and

        -  To correlate the appearance of metastasis-specific mutations in the ctDNA with
           histological features in the tumours such as degree of necrosis, inflammation,
           microvascular density, and location or size of primary tumour and metastases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony Joshua, Dr.
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Melanoma