<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/NCT03298438</url>
  </required_header>
  <id_info>
    <org_study_id>NF1</org_study_id>
    <nct_id>NCT03298438</nct_id>
  </id_info>
  <brief_title>Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms</brief_title>
  <acronym>NF1</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic&#xD;
      disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in&#xD;
      patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was&#xD;
      retained according to NIH criteria, familial forms were excluded. The French version of the&#xD;
      Impact of Event Scale-Revised was used for the diagnosis of PTSD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form</measure>
    <time_frame>Day 1 after diagnosis of neurofibromatosis</time_frame>
    <description>Questionnaire Impact of Event Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Study methods of annoucement and feeling of patients with a questionnaire</measure>
    <time_frame>Day 1 after diagnosis of neurofibromatosis</time_frame>
    <description>Questionnaires about: methods of announcement (who? when? how?)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetical analyze</measure>
    <time_frame>Day 1 after diagnosis of neurofibromatosis</time_frame>
    <description>Genetical analyze</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological or psychiatrical impact</measure>
    <time_frame>Day 1 after diagnosis of neurofibromatosis</time_frame>
    <description>Psychological or psychiatrical impact</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Information about NF1</measure>
    <time_frame>Day 1 after diagnosis of neurofibromatosis</time_frame>
    <description>Questions about look for information about disease</description>
  </secondary_outcome>
  <enrollment type="Actual">31</enrollment>
  <condition>Neurofibromatosis 1</condition>
  <condition>Diagnoses Disease</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients or parent of a children followed for a neurofibromatosis type 1 in de novo&#xD;
        form&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 or more, or parent of a children&#xD;
&#xD;
          -  Patient with a neurofibromatosis type 1 or parent of a children with a&#xD;
             neurofibromatosis 1 in de novo form&#xD;
&#xD;
          -  Followed for a neurofibromatosis type 1 de novo at the dedicated consultation in the&#xD;
             University Hospital of Brest, since april 2013&#xD;
&#xD;
          -  Agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged of 18 years old or lower&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 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>Neurofibromatoses</mesh_term>
    <mesh_term>Neurofibromatosis 1</mesh_term>
    <mesh_term>Neurofibroma</mesh_term>
    <mesh_term>Disease</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT03298438
org study id: NF1
nct id: NCT03298438
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic
      disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in
      patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was
      retained according to NIH criteria, familial forms were excluded. The French version of the
      Impact of Event Scale-Revised was used for the diagnosis of PTSD.
observational model: Cohort
time perspective: Prospective
measure: Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form
time frame: Day 1 after diagnosis of neurofibromatosis
description: Questionnaire Impact of Event Scale
measure: Study methods of annoucement and feeling of patients with a questionnaire
time frame: Day 1 after diagnosis of neurofibromatosis
description: Questionnaires about: methods of announcement (who? when? how?)
measure: Genetical analyze
time frame: Day 1 after diagnosis of neurofibromatosis
description: Genetical analyze
measure: Psychological or psychiatrical impact
time frame: Day 1 after diagnosis of neurofibromatosis
description: Psychological or psychiatrical impact
measure: Information about NF1
time frame: Day 1 after diagnosis of neurofibromatosis
description: Questions about look for information about disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Neurofibromatoses
mesh term: Neurofibromatosis 1
mesh term: Neurofibroma
mesh term: Disease
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic