<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/NCT01707836</url>
  </required_header>
  <id_info>
    <org_study_id>201208141</org_study_id>
    <nct_id>NCT01707836</nct_id>
  </id_info>
  <brief_title>Neurofibromatosis Type 1 Brain Tumor Genetic Risk</brief_title>
  <official_title>Genetic Variation and Risk of Pediatric Brain Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will analyze DNA samples to determine associations between maternal and offspring&#xD;
      genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type&#xD;
      1. Participating families (mother, father, child) will be asked to complete a short&#xD;
      questionnaire and provide DNA samples (either saliva or blood). The information gained from&#xD;
      your participation may one day help doctors develop strategies to reduce brain tumor risk in&#xD;
      individuals with NF1. Please note: there is no therapy associated with this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prenatal period is a developmentally vulnerable time point during which environmental&#xD;
      conditions, including nutrition, can have life-long impacts on health.1,2 This is&#xD;
      particularly relevant to many childhood cancers that are thought to initiate during&#xD;
      pregnancy.3 As a consequence, there has been intense interest in whether prenatal exposures&#xD;
      can modulate childhood cancer risk.4-6 It is important to recognize that both maternal and&#xD;
      offspring genetic factors including those in nutritional pathways may play an important role&#xD;
      in pediatric cancer risk through their effect on the child's exposure to nutrients important&#xD;
      in development during the prenatal period. The purpose of this research study is to evaluate&#xD;
      whether there are any maternal or offspring genetic factors in the folate pathway that may&#xD;
      contribute to the development of brain tumors in children with Neurofibromatosis Type 1&#xD;
      through analysis of DNA samples collected from families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 8, 2017</completion_date>
  <primary_completion_date type="Actual">May 8, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain Tumor</measure>
    <time_frame>September 1, 2012-February 1, 2014</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">176</enrollment>
  <condition>Neurofibromatosis Type 1</condition>
  <condition>Pediatric Brain Tumor</condition>
  <arm_group>
    <arm_group_label>Family</arm_group_label>
    <description>Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood or saliva samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Families will be recruited from the Washingington University Neurofibromatosis-1 (NF1)&#xD;
        Patient Registry Initiative (NPRI) and NF Center Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric participant (born during 1994-2012) with NF1 and diagnosed with a brain&#xD;
             tumor&#xD;
&#xD;
          -  Biological mother or father (or full sibling if mother or father is unable to&#xD;
             participate) able to participate&#xD;
&#xD;
          -  All family members (pediatric participant, biological mother, and biological father or&#xD;
             full sibling) must be willing to contribute a blood or saliva sample&#xD;
&#xD;
          -  ability to understand consent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -those who do not meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly J Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>May 8, 2017</last_update_submitted>
  <last_update_submitted_qc>May 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Neurofibromatoses</mesh_term>
    <mesh_term>Neurofibromatosis 1</mesh_term>
    <mesh_term>Neurofibroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01707836
org study id: 201208141
nct id: NCT01707836
lead sponsor: 
has dmc: No
This study will analyze DNA samples to determine associations between maternal and offspring
      genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type
      1. Participating families (mother, father, child) will be asked to complete a short
      questionnaire and provide DNA samples (either saliva or blood). The information gained from
      your participation may one day help doctors develop strategies to reduce brain tumor risk in
      individuals with NF1. Please note: there is no therapy associated with this study.
The prenatal period is a developmentally vulnerable time point during which environmental
      conditions, including nutrition, can have life-long impacts on health.1,2 This is
      particularly relevant to many childhood cancers that are thought to initiate during
      pregnancy.3 As a consequence, there has been intense interest in whether prenatal exposures
      can modulate childhood cancer risk.4-6 It is important to recognize that both maternal and
      offspring genetic factors including those in nutritional pathways may play an important role
      in pediatric cancer risk through their effect on the child's exposure to nutrients important
      in development during the prenatal period. The purpose of this research study is to evaluate
      whether there are any maternal or offspring genetic factors in the folate pathway that may
      contribute to the development of brain tumors in children with Neurofibromatosis Type 1
      through analysis of DNA samples collected from families.
observational model: Family-Based
time perspective: Cross-Sectional
measure: Brain Tumor
time frame: September 1, 2012-February 1, 2014
arm group label: Family
description: Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor.
Blood or saliva samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Kimberly J Johnson, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Neoplasms
mesh term: Neurofibromatoses
mesh term: Neurofibromatosis 1
mesh term: Neurofibroma
sharing ipd: Undecided