<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/NCT01679925</url>
  </required_header>
  <id_info>
    <org_study_id>P111010</org_study_id>
    <nct_id>NCT01679925</nct_id>
  </id_info>
  <brief_title>Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years</brief_title>
  <acronym>PUPSY</acronym>
  <official_title>Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      GnRH agonists are used in the treatment of precocious puberty in order to improve adult&#xD;
      height.However,the psychosocial impact of precocious puberty is often used by the clinician&#xD;
      at diagnosis to justify treatment, but can not yet be properly assessed. It can not be&#xD;
      considered as a rational neither for the indication to treatment, nor to assess its potential&#xD;
      efficacy.&#xD;
&#xD;
      The overall objective of this work is to improve the conditions leading to the therapeutic&#xD;
      decision and the procedures for monitoring girls with idiopathic central precocious puberty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the day hospital, the diagnostic workup for precocious puberty will be performed and&#xD;
      include:&#xD;
&#xD;
        -  A clinical examination with pubertal stage assessment.&#xD;
&#xD;
        -  A GnRH test&#xD;
&#xD;
        -  A Pelvic ultrasound&#xD;
&#xD;
        -  An MRI will be performed later after the results of GnRH test confirming precocious&#xD;
           central puberty.&#xD;
&#xD;
      These reviews are conducted as part of usual care and are required to validate the inclusion&#xD;
      criteria of patients.&#xD;
&#xD;
      The CBCL questionnaire will be completed by patient's parents and the first semi-structured&#xD;
      interview will be conducted by a sociologist assisted by the psychologist, dedicated to the&#xD;
      study.&#xD;
&#xD;
      Patient's follow-up will be planned 6 months after inclusion, including similar&#xD;
      investigations (except MRI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Psychosocial characteristics</measure>
    <time_frame>1 day</time_frame>
    <description>The thematic content related to the perception of early puberty, the factors motivating the consultation, the concerns of families and children, psychosocial characteristics of the subjects received in consultation.&#xD;
The thematic content related to the perception of hormone therapy: identifying the knowledge, concerns and expectations regarding the treatment of precocious puberty.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Behavior Checklist</measure>
    <time_frame>1 day</time_frame>
    <description>Quantitative data on the psychosocial status of patients will be collected as a self-administered questionnaire: the Child Behavior Checklist (CBCL) that is validated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Early Puberty</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be offered to all children and families who visit in a day hospital in the&#xD;
        pediatric endocrinology department of Robert Debré Hospital for further assessment of early&#xD;
        puberty.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6 to 8 years old girls, with idiopathic central precocious puberty defined as:&#xD;
&#xD;
               -  Onset of clinical signs between 6 and 8 years excluded: breast development&#xD;
                  (Tanner stage S2 or more), possibly with pubic hair or accelerated growth rate.&#xD;
&#xD;
               -  The GnRH test: LH peak&gt; 5 IU / l during the test.&#xD;
&#xD;
               -  Pelvic ultrasound: uterine length&gt; 34 mm&#xD;
&#xD;
               -  The normality of the hypothalamic-pituitary region assessed by magnetic resonance&#xD;
                  imaging (MRI).&#xD;
&#xD;
          -  Parental Informed and written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents and / or children do not speak French&#xD;
&#xD;
          -  Other chronic disease&#xD;
&#xD;
          -  The child does not benefit of the French social security cover&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique SIMON, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique - Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>July 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early puberty</keyword>
  <keyword>Psychosocial impact</keyword>
  <keyword>Qualitative assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puberty, Precocious</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/NCT01679925
org study id: P111010
nct id: NCT01679925
lead sponsor: 
has dmc: No
GnRH agonists are used in the treatment of precocious puberty in order to improve adult
      height.However,the psychosocial impact of precocious puberty is often used by the clinician
      at diagnosis to justify treatment, but can not yet be properly assessed. It can not be
      considered as a rational neither for the indication to treatment, nor to assess its potential
      efficacy.

      The overall objective of this work is to improve the conditions leading to the therapeutic
      decision and the procedures for monitoring girls with idiopathic central precocious puberty.
During the day hospital, the diagnostic workup for precocious puberty will be performed and
      include:

        -  A clinical examination with pubertal stage assessment.

        -  A GnRH test

        -  A Pelvic ultrasound

        -  An MRI will be performed later after the results of GnRH test confirming precocious
           central puberty.

      These reviews are conducted as part of usual care and are required to validate the inclusion
      criteria of patients.

      The CBCL questionnaire will be completed by patient's parents and the first semi-structured
      interview will be conducted by a sociologist assisted by the psychologist, dedicated to the
      study.

      Patient's follow-up will be planned 6 months after inclusion, including similar
      investigations (except MRI).
observational model: Cohort
time perspective: Prospective
measure: Psychosocial characteristics
time frame: 1 day
description: The thematic content related to the perception of early puberty, the factors motivating the consultation, the concerns of families and children, psychosocial characteristics of the subjects received in consultation.
The thematic content related to the perception of hormone therapy: identifying the knowledge, concerns and expectations regarding the treatment of precocious puberty.
measure: Child Behavior Checklist
time frame: 1 day
description: Quantitative data on the psychosocial status of patients will be collected as a self-administered questionnaire: the Child Behavior Checklist (CBCL) that is validated.
measure: Evolution at 6 months
time frame: 6 months
description: Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 6 Years
maximum age: 8 Years
healthy volunteers: No
last name: Dominique SIMON, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Puberty, Precocious