<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/NCT01668251</url>
  </required_header>
  <id_info>
    <org_study_id>TS Prenatal Study</org_study_id>
    <nct_id>NCT01668251</nct_id>
  </id_info>
  <brief_title>Turner Syndrome Prenatal Diagnosis Study</brief_title>
  <official_title>National Collaborative Study of Girls Prenatally Diagnosed With Turner Syndrome Karyotypes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to compare the features of Turner syndrome in girls who are&#xD;
      diagnosed before birth because of fetal concerns versus those who are diagnosed when their&#xD;
      mother has an amniocentesis for another reason.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study which will look at girls who are diagnosed with Turner&#xD;
      syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed&#xD;
      because of features seen on ultrasound which raised the question of Turner syndrome and 2)&#xD;
      those diagnosed incidentally when their mother had an amniocentesis for another reason such&#xD;
      as advanced maternal age.&#xD;
&#xD;
      No clinical procedures nor interventions will be done as part of this data collection study&#xD;
      which will occur for the first 3 to 6 years of the girl's life. The investigators will be&#xD;
      looking to see if girls who are diagnosed incidentally have less features of Turner syndrome&#xD;
      than those girls who are diagnosed because of fetal ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2006</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Number of signs of Turner syndrome</measure>
    <time_frame>three to six years</time_frame>
    <description>Girls diagnosed with Turner syndrome by fetal ascertainment will have more signs of Turner syndrome than girls diagnosed by maternal ascertainment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>three to six years</time_frame>
    <description>Do girls with Turner syndrome ascertained by fetal ascertainment grow differently than girls ascertained by maternal ascertainment.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Turner Syndrome</condition>
  <arm_group>
    <arm_group_label>Fetal ascertainment</arm_group_label>
    <description>Girls who are diagnosed with Turner syndrome because of concerns raised by an abnormal fetal ultrasound.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maternal ascertainment</arm_group_label>
    <description>Girls who are diagnosed with Turner syndrome because their mothers had an amniocentesis for a reason other than an abnormal fetal ultrasound concerning for Turner syndrome. For example an amniocentesis was done because of advanced maternal age or because of an abnormal triple screen or because another condition was being screened for such as trisomy 21.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Girls who are diagnosed with Turner syndrome prenatally.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Turner syndrome diagnosed prenatally&#xD;
&#xD;
          -  Less than 4 months of age at time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Turner syndrome diagnosed postnatally&#xD;
&#xD;
          -  Older than 4 months of age at time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Fechner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patricia Fechner, MD</last_name>
    <phone>206-987-5037</phone>
    <email>patricia.fechner@seattlechildrens.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Fechner, M.D.</last_name>
      <phone>800-317-7589</phone>
      <email>patricia.fechner@seattlechildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>Sue Kearns, RN</last_name>
      <phone>1-206-987-1758</phone>
      <email>sue.kearns@seattlechildrens.org</email>
    </contact_backup>
    <investigator>
      <last_name>Patricia Fechner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gunther DF, Eugster E, Zagar AJ, Bryant CG, Davenport ML, Quigley CA. Ascertainment bias in Turner syndrome: new insights from girls who were diagnosed incidentally in prenatal life. Pediatrics. 2004 Sep;114(3):640-4. doi: 10.1542/peds.2003-1122-L.</citation>
    <PMID>15342833</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>November 3, 2011</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Patricia Fechner</investigator_full_name>
    <investigator_title>Associate Professor, Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Turner syndrome</keyword>
  <keyword>Diagnosis, prenatal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Turner Syndrome</mesh_term>
    <mesh_term>Gonadal Dysgenesis</mesh_term>
    <mesh_term>Syndrome</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/NCT01668251
org study id: TS Prenatal Study
nct id: NCT01668251
lead sponsor: 
collaborator: 
has dmc: No
The goal of this study is to compare the features of Turner syndrome in girls who are
      diagnosed before birth because of fetal concerns versus those who are diagnosed when their
      mother has an amniocentesis for another reason.
This is an observational study which will look at girls who are diagnosed with Turner
      syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed
      because of features seen on ultrasound which raised the question of Turner syndrome and 2)
      those diagnosed incidentally when their mother had an amniocentesis for another reason such
      as advanced maternal age.

      No clinical procedures nor interventions will be done as part of this data collection study
      which will occur for the first 3 to 6 years of the girl's life. The investigators will be
      looking to see if girls who are diagnosed incidentally have less features of Turner syndrome
      than those girls who are diagnosed because of fetal ultrasound.
observational model: Case-Control
time perspective: Prospective
measure: Number of signs of Turner syndrome
time frame: three to six years
description: Girls diagnosed with Turner syndrome by fetal ascertainment will have more signs of Turner syndrome than girls diagnosed by maternal ascertainment
measure: Growth
time frame: three to six years
description: Do girls with Turner syndrome ascertained by fetal ascertainment grow differently than girls ascertained by maternal ascertainment.
arm group label: Fetal ascertainment
description: Girls who are diagnosed with Turner syndrome because of concerns raised by an abnormal fetal ultrasound.
arm group label: Maternal ascertainment
description: Girls who are diagnosed with Turner syndrome because their mothers had an amniocentesis for a reason other than an abnormal fetal ultrasound concerning for Turner syndrome. For example an amniocentesis was done because of advanced maternal age or because of an abnormal triple screen or because another condition was being screened for such as trisomy 21.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: 3 Months
healthy volunteers: No
last name: Patricia Fechner, MD
role: Principal Investigator
affiliation: Seattle Children's
last name: Patricia Fechner, MD
phone: 206-987-5037
email: patricia.fechner@seattlechildrens.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Gunther DF, Eugster E, Zagar AJ, Bryant CG, Davenport ML, Quigley CA. Ascertainment bias in Turner syndrome: new insights from girls who were diagnosed incidentally in prenatal life. Pediatrics. 2004 Sep;114(3):640-4. doi: 10.1542/peds.2003-1122-L.
PMID: 15342833
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Patricia Fechner
investigator title: Associate Professor, Pediatrics
mesh term: Turner Syndrome
mesh term: Gonadal Dysgenesis
mesh term: Syndrome