xml: <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/NCT06018831</url>
    </required_header>
    <id_info>
      <org_study_id>2021YFC2500202</org_study_id>
      <nct_id>NCT06018831</nct_id>
    </id_info>
    <brief_title>Urine and Ultrasound Screening for Kidney Disease in Children</brief_title>
    <official_title>Urine and Ultrasound Screening for Kidney Disease in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital of Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kunshan City Maternal and Child Health Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qidong City Maternal and Child Health Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Hospital of Fudan University</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>
        The aim of this study is to early detect kidney disease in the natural population cohort of&#xD;
        children by urine and ultrasound screening, to assist in the precise prevention and treatment&#xD;
        of children's kidney disease, and to establish a risk prediction system for children's kidney&#xD;
        disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in&#xD;
        Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who&#xD;
        is found with abnormal urine or ultrasound result will be referred to Children's Hospital of&#xD;
        Fudan University to get further examination and treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic kidney disease (CKD) often has an insidious onset. Early detection of CKD and more&#xD;
        aggressive treatment and monitoring of high-risk CKD patients at risk of progression are the&#xD;
        consensus of current medical practice. However, there is currently no CKD risk prediction&#xD;
        system for the Chinese population, especially children. The main goal of this project is to&#xD;
        establish a risk prediction system for children's kidney disease, and to assist in the&#xD;
        precise prevention and treatment of children's kidney disease. The project is based on the&#xD;
        &quot;urine and ultrasound screening&quot; strategy that has been carried out for more than ten years&#xD;
        in Shanghai, using a non-invasive and effective screening method in the natural population&#xD;
        cohort of children, in order to detect kidney disease in the early stage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 12, 2022</start_date>
    <completion_date type="Anticipated">February 2028</completion_date>
    <primary_completion_date type="Anticipated">February 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence, incidence, and incidence of renal disease progression in children with CKD</measure>
      <time_frame>From baseline to the third or sixth year of the study</time_frame>
      <description>The number of CKD patients diagnosed according to the routine diagnosis and treatment of the department of nephrology in Children's Hospital of Fudan University in the 3-6 year observation period accounted for the percentage of the total cases studied.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Urine metabolomic and proteomic profiles in KunQi Cohort</measure>
      <time_frame>From baseline to the third or sixth year of the study</time_frame>
      <description>9,000 children's urine samples (50ml) will be stored as biospecimen retention at -80°C only once within one year, another 1,000 children's urine samples (50ml) will be stored also as biospecimen retention at -80°C once a year.&#xD;
  Biospecimen retention will be used to characterize the urinary and metabolome and proteome in children also expect to identify urine biomarkers for the early diagnosis of CKD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood metabolomic and DNA profiles in KunQi Cohort</measure>
      <time_frame>From baseline to the third or sixth year of the study</time_frame>
      <description>Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for metabolomic study and DNA extraction, aiming to identify blood metabolomic biomarkers and DNA mutations for the early diagnosis of CKD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children</measure>
      <time_frame>From baseline to the third or sixth year of the study</time_frame>
      <description>Every child's patient will be asked to complete 3-6 year follow-up questionnaire once a year(include Children Kidney Health Survey for first-year baseline questionnaire and Chilren Kidney Health Survey as every year's follow-up questionnaire) when undergoing routine child health checkups, which includes health conditions and kidney disease related events including family history, mother's height and weight before and after pregnancy (used to calculate BMI), parents' smoking and drinking history, whether the mother takes antihypertensive drugs and the type, parents' occupational exposure history, drinking water quality, take-out frequency, mother's first child bearing age and the age of this child bearing, newborn hospitalization history. These potential risk factors analyzed by statistical methods are aimed to predict the onset, development and prognosis of CKD in children.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">13000</enrollment>
    <condition>Kidney Diseases</condition>
    <condition>Diagnostic Techniques</condition>
    <condition>Ultrasound</condition>
    <condition>Urinalysis</condition>
    <condition>Child, Only</condition>
    <arm_group>
      <arm_group_label>Urine and Ultrasound Screening</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Children will receive urine and ultrasound screening in 0-3 months ,and complete 3 to 6 years of follow-up( at least one type screening every year)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Urine and Ultrasound Screening</intervention_name>
      <description>When an infant was born, he/she will receive the first urine and ultrasound screening in 3 months in Kunshan/Qidong City Maternal and Child Health Hospital.In Kunqi Cohort, 9,000 will complete 3 years follow-up(urine screening once every year, another ultrasound screening in 24-30 months). Urine sample (50ml) will be stored only once within one year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study.1,000 children will complete 6 year follow-up(receive urine and ultrasound screening once every year). Urine sample (50ml) will be stored once a year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study. The 14 urine test items include: leukocytes, urobilinogen, microalbumin, protein, bilirubin, glucose, ascorbic acid, specific gravity, ketone bodies, nitrite, creatinine, pH, occult blood, and urinary calcium. Ultrasound test will screen for kidneys, ureters and the bladder.</description>
      <arm_group_label>Urine and Ultrasound Screening</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All consecutive live newborn infants(regardless of physical condition)&#xD;
  &#xD;
            -  Complete at least 3 years of follow-up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Declining the screening&#xD;
  &#xD;
            -  Missing&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yihui Zhai</last_name>
      <phone>+8613916488230</phone>
      <email>marinezyh@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hong Xu, PhD.MD.</last_name>
      <phone>+8602164932829</phone>
      <email>hxu@shmu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Qidong City Maternal and Child Health Hospital</name>
        <address>
          <city>Nantong</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>JuanJuan Wu</last_name>
        <phone>+8613862875600</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Gong Y, Zhang Y, Shen Q, Xiao L, Zhai Y, Bi Y, Shen J, Chen H, Li Y, Xu H. Early detection of congenital anomalies of the kidney and urinary tract: cross-sectional results of a community-based screening and referral study in China. BMJ Open. 2018 May 30;8(5):e020634. doi: 10.1136/bmjopen-2017-020634.</citation>
      <PMID>29848771</PMID>
    </reference>
    <reference>
      <citation>Gong Y, Xu H, Li Y, Zhou Y, Zhang M, Shen Q, Huang J, Xu H, Bi Y, Chen H, Zhang Y, Wang J. Exploration of postnatal integrated management for prenatal renal and urinary tract anomalies in China. J Matern Fetal Neonatal Med. 2021 Feb;34(3):360-365. doi: 10.1080/14767058.2019.1608176. Epub 2019 Apr 29.</citation>
      <PMID>30983458</PMID>
    </reference>
    <reference>
      <citation>Zhai YH, Xu H, Zhu GH, Wei MJ, Hua BC, Shen Q, Rao J, Ge J. Efficacy of urine screening at school: experience in Shanghai, China. Pediatr Nephrol. 2007 Dec;22(12):2073-9. doi: 10.1007/s00467-007-0629-5. Epub 2007 Oct 18.</citation>
      <PMID>17943322</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</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>Kidney Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018831
  org study id: 2021YFC2500202
  nct id: NCT06018831
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to early detect kidney disease in the natural population cohort of
        children by urine and ultrasound screening, to assist in the precise prevention and treatment
        of children's kidney disease, and to establish a risk prediction system for children's kidney
        disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in
        Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who
        is found with abnormal urine or ultrasound result will be referred to Children's Hospital of
        Fudan University to get further examination and treatment.
  Chronic kidney disease (CKD) often has an insidious onset. Early detection of CKD and more
        aggressive treatment and monitoring of high-risk CKD patients at risk of progression are the
        consensus of current medical practice. However, there is currently no CKD risk prediction
        system for the Chinese population, especially children. The main goal of this project is to
        establish a risk prediction system for children's kidney disease, and to assist in the
        precise prevention and treatment of children's kidney disease. The project is based on the
        "urine and ultrasound screening" strategy that has been carried out for more than ten years
        in Shanghai, using a non-invasive and effective screening method in the natural population
        cohort of children, in order to detect kidney disease in the early stage.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Prevalence, incidence, and incidence of renal disease progression in children with CKD
  time frame: From baseline to the third or sixth year of the study
  description: The number of CKD patients diagnosed according to the routine diagnosis and treatment of the department of nephrology in Children's Hospital of Fudan University in the 3-6 year observation period accounted for the percentage of the total cases studied.
  measure: Urine metabolomic and proteomic profiles in KunQi Cohort
  time frame: From baseline to the third or sixth year of the study
  description: 9,000 children's urine samples (50ml) will be stored as biospecimen retention at -80°C only once within one year, another 1,000 children's urine samples (50ml) will be stored also as biospecimen retention at -80°C once a year.
  Biospecimen retention will be used to characterize the urinary and metabolome and proteome in children also expect to identify urine biomarkers for the early diagnosis of CKD.
  measure: Blood metabolomic and DNA profiles in KunQi Cohort
  time frame: From baseline to the third or sixth year of the study
  description: Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for metabolomic study and DNA extraction, aiming to identify blood metabolomic biomarkers and DNA mutations for the early diagnosis of CKD.
  measure: Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children
  time frame: From baseline to the third or sixth year of the study
  description: Every child's patient will be asked to complete 3-6 year follow-up questionnaire once a year(include Children Kidney Health Survey for first-year baseline questionnaire and Chilren Kidney Health Survey as every year's follow-up questionnaire) when undergoing routine child health checkups, which includes health conditions and kidney disease related events including family history, mother's height and weight before and after pregnancy (used to calculate BMI), parents' smoking and drinking history, whether the mother takes antihypertensive drugs and the type, parents' occupational exposure history, drinking water quality, take-out frequency, mother's first child bearing age and the age of this child bearing, newborn hospitalization history. These potential risk factors analyzed by statistical methods are aimed to predict the onset, development and prognosis of CKD in children.
  arm group label: Urine and Ultrasound Screening
  arm group type: Experimental
  description: About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Children will receive urine and ultrasound screening in 0-3 months ,and complete 3 to 6 years of follow-up( at least one type screening every year)
  intervention type: Other
  intervention name: Urine and Ultrasound Screening
  description: When an infant was born, he/she will receive the first urine and ultrasound screening in 3 months in Kunshan/Qidong City Maternal and Child Health Hospital.In Kunqi Cohort, 9,000 will complete 3 years follow-up(urine screening once every year, another ultrasound screening in 24-30 months). Urine sample (50ml) will be stored only once within one year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study.1,000 children will complete 6 year follow-up(receive urine and ultrasound screening once every year). Urine sample (50ml) will be stored once a year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study. The 14 urine test items include: leukocytes, urobilinogen, microalbumin, protein, bilirubin, glucose, ascorbic acid, specific gravity, ketone bodies, nitrite, creatinine, pH, occult blood, and urinary calcium. Ultrasound test will screen for kidneys, ureters and the bladder.
  arm group label: Urine and Ultrasound Screening
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yihui Zhai
  phone: +8613916488230
  email: marinezyh@163.com
  last name: Hong Xu, PhD.MD.
  phone: +8602164932829
  email: hxu@shmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Gong Y, Zhang Y, Shen Q, Xiao L, Zhai Y, Bi Y, Shen J, Chen H, Li Y, Xu H. Early detection of congenital anomalies of the kidney and urinary tract: cross-sectional results of a community-based screening and referral study in China. BMJ Open. 2018 May 30;8(5):e020634. doi: 10.1136/bmjopen-2017-020634.
  PMID: 29848771
  citation: Gong Y, Xu H, Li Y, Zhou Y, Zhang M, Shen Q, Huang J, Xu H, Bi Y, Chen H, Zhang Y, Wang J. Exploration of postnatal integrated management for prenatal renal and urinary tract anomalies in China. J Matern Fetal Neonatal Med. 2021 Feb;34(3):360-365. doi: 10.1080/14767058.2019.1608176. Epub 2019 Apr 29.
  PMID: 30983458
  citation: Zhai YH, Xu H, Zhu GH, Wei MJ, Hua BC, Shen Q, Rao J, Ge J. Efficacy of urine screening at school: experience in Shanghai, China. Pediatr Nephrol. 2007 Dec;22(12):2073-9. doi: 10.1007/s00467-007-0629-5. Epub 2007 Oct 18.
  PMID: 17943322
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  sharing ipd: No