<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/NCT02969174</url>
  </required_header>
  <id_info>
    <org_study_id>ShangjiTongjiHsxk</org_study_id>
    <nct_id>NCT02969174</nct_id>
  </id_info>
  <brief_title>Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.</brief_title>
  <official_title>Clinical Professor of Shanghai Tongji Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Tongji Hospital, Tongji University School of Medicine</source>
  <brief_summary>
    <textblock>
      To establish a genotyping and extraction technology of non invasive prenatal diagnosis for&#xD;
      fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.&#xD;
&#xD;
      To achieve prenatal accurate identification of fetal blood group genotypes，and provide&#xD;
      credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease&#xD;
      of newborn (HDN).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat&#xD;
      the HDN.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>HDFN</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>zimin Lu,Guo Sa</intervention_name>
    <description>chengzhong Liu</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        blood samples of pregnant couples,gender/nation/region is unlimited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        adipose or hemolytic samples,overdue samples,unidentified samples&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Weeks</minimum_age>
    <maximum_age>38 Weeks</maximum_age>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Tongji Hospital, Tongji University School of Medicine</investigator_affiliation>
    <investigator_full_name>Liming Cheng</investigator_full_name>
    <investigator_title>The President of Shanghai Tongji Hospital</investigator_title>
  </responsible_party>
  <!-- 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/NCT02969174
org study id: ShangjiTongjiHsxk
nct id: NCT02969174
lead sponsor: 
To establish a genotyping and extraction technology of non invasive prenatal diagnosis for
      fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.

      To achieve prenatal accurate identification of fetal blood group genotypes，and provide
      credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease
      of newborn (HDN).
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat
      the HDN.
intervention type: Other
intervention name: zimin Lu,Guo Sa
description: chengzhong Liu
criteria: 
gender: All
minimum age: 12 Weeks
maximum age: 38 Weeks
responsible party type: Principal Investigator
investigator affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
investigator full name: Liming Cheng
investigator title: The President of Shanghai Tongji Hospital