<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/NCT03235128</url>
  </required_header>
  <id_info>
    <org_study_id>CSOAOSM</org_study_id>
    <nct_id>NCT03235128</nct_id>
  </id_info>
  <brief_title>Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome</brief_title>
  <official_title>Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Childhood nephrotic syndrome is the most frequent glomerular disease that presents during&#xD;
      childhood,primarily owing to a disturbed immune function.This disease is characterized by&#xD;
      alterations in selectivity at the glomerular capillary wall that lead to an inability to&#xD;
      restrict the urinary loss of protein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood nephrotic syndrome is the most frequent glomerular disease that presents during&#xD;
      childhood,primarily owing to a disturbed immune function.This disease is characterized by&#xD;
      alterations in selectivity at the glomerular capillary wall that lead to an inability to&#xD;
      restrict the urinary loss of protein.The syndrome is characterized by the tetrad of nephrotic&#xD;
      range proteinuria (&gt;40 mg/m2/hour), hypoalbuminemia (&lt;2.5 g/dl), generalized edema, and&#xD;
      hyperlipidemia. It can be congenital or acquired.Currently,serum albumin, lipids, and&#xD;
      proteinuria are the common diagnostic markers of childhood NS, but these markers may not&#xD;
      accurately predict the outcome of individual patients because of the heterogeneity of the&#xD;
      disease. Renal biopsy is more precise for establishing prognosis of renal outcome, but it has&#xD;
      potential complications. Repeated monitoring is technically difficult, particularly for&#xD;
      children. Therefore, there is still an urgent need to identify new non invasive diagnostic&#xD;
      and prognostic biomarkers and new therapeutic targets for this disease.miRNA-30a expression&#xD;
      in the serum of patients with nephrotic syndrome and analyzed the correlation between miRNA&#xD;
      with largest over expression level and clinical features compared with healthy&#xD;
      subjects.miRNA-30a expression level in drug resistant nephrotic syndrome patients was&#xD;
      obviously higher than the drug sensitive patients and up-regulated most significantly in&#xD;
      mesangial proliferative glomerulonephritis among different pathological types, while it&#xD;
      decreased most obviously in glomerular lesions. miRNA-30a could be treated as the molecular&#xD;
      marker in predict drug resistance, pathological type of nephrotic syndrome and follow up of&#xD;
      resistant cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with highly expressed serum miRNA30-a in resistant cases of childhood nephrotic syndrome.</measure>
    <time_frame>3 days</time_frame>
    <description>Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Nephrotic Syndrome Steroid-Resistant</condition>
  <arm_group>
    <arm_group_label>Group1</arm_group_label>
    <description>Steroid sensitive nephrotic syndrome(10 cases).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group2</arm_group_label>
    <description>Steroid resistant nephrotic syndrome(10 cases).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group3</arm_group_label>
    <description>immunosuppressive resistant nephrotic syndrome(10 cases).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group4</arm_group_label>
    <description>Refractory nephrotic syndrome(10 cases).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group5</arm_group_label>
    <description>Normal children as a healthy control group(5 cases).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.</intervention_name>
    <description>Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood</description>
    <arm_group_label>Group1</arm_group_label>
    <arm_group_label>Group2</arm_group_label>
    <arm_group_label>Group3</arm_group_label>
    <arm_group_label>Group4</arm_group_label>
    <arm_group_label>Group5</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group1: steroid sensitive nephrotic syndrome ( 10 cases ). Group2:steroid resistant&#xD;
        nephrotic syndrome (10 cases). Group3:immunosuppresive resistant nephrotic syndrome(10&#xD;
        cases). Group4:refractory nephrotic syndrome(10 cases). Group5: normal children as a&#xD;
        healthy control group ( 5 cases ).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Nephrotic children aged from 2 to 18 that admitted to Pediatric Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital or infantile nephrotic syndrome&#xD;
&#xD;
          -  Other kidney diseases&#xD;
&#xD;
          -  Abnormal kidney function test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hanan Omar Mohamed, Professor Doctor</last_name>
    <phone>01223971654</phone>
    <email>hannahomer@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eman Mohammed Salaheldin, Lecturer</last_name>
    <phone>01028030966</phone>
    <email>emansalah.eldin@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Teng J, Sun F, Yu PF, Li JX, Yuan D, Chang J, Lin SH. Differential microRNA expression in the serum of patients with nephrotic syndrome and clinical correlation analysis. Int J Clin Exp Pathol. 2015 Jun 1;8(6):7282-6. eCollection 2015.</citation>
    <PMID>26261628</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>RAMahmoud</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrotic Syndrome</mesh_term>
    <mesh_term>Nephrosis</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/NCT03235128
org study id: CSOAOSM
nct id: NCT03235128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Childhood nephrotic syndrome is the most frequent glomerular disease that presents during
      childhood,primarily owing to a disturbed immune function.This disease is characterized by
      alterations in selectivity at the glomerular capillary wall that lead to an inability to
      restrict the urinary loss of protein.
Childhood nephrotic syndrome is the most frequent glomerular disease that presents during
      childhood,primarily owing to a disturbed immune function.This disease is characterized by
      alterations in selectivity at the glomerular capillary wall that lead to an inability to
      restrict the urinary loss of protein.The syndrome is characterized by the tetrad of nephrotic
      range proteinuria (>40 mg/m2/hour), hypoalbuminemia (<2.5 g/dl), generalized edema, and
      hyperlipidemia. It can be congenital or acquired.Currently,serum albumin, lipids, and
      proteinuria are the common diagnostic markers of childhood NS, but these markers may not
      accurately predict the outcome of individual patients because of the heterogeneity of the
      disease. Renal biopsy is more precise for establishing prognosis of renal outcome, but it has
      potential complications. Repeated monitoring is technically difficult, particularly for
      children. Therefore, there is still an urgent need to identify new non invasive diagnostic
      and prognostic biomarkers and new therapeutic targets for this disease.miRNA-30a expression
      in the serum of patients with nephrotic syndrome and analyzed the correlation between miRNA
      with largest over expression level and clinical features compared with healthy
      subjects.miRNA-30a expression level in drug resistant nephrotic syndrome patients was
      obviously higher than the drug sensitive patients and up-regulated most significantly in
      mesangial proliferative glomerulonephritis among different pathological types, while it
      decreased most obviously in glomerular lesions. miRNA-30a could be treated as the molecular
      marker in predict drug resistance, pathological type of nephrotic syndrome and follow up of
      resistant cases.
observational model: Case-Control
time perspective: Retrospective
measure: Percentage of patients with highly expressed serum miRNA30-a in resistant cases of childhood nephrotic syndrome.
time frame: 3 days
description: Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.
arm group label: Group1
description: Steroid sensitive nephrotic syndrome(10 cases).
arm group label: Group2
description: Steroid resistant nephrotic syndrome(10 cases).
arm group label: Group3
description: immunosuppressive resistant nephrotic syndrome(10 cases).
arm group label: Group4
description: Refractory nephrotic syndrome(10 cases).
arm group label: Group5
description: Normal children as a healthy control group(5 cases).
intervention type: Diagnostic Test
intervention name: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.
description: Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood
arm group label: Group1
arm group label: Group2
arm group label: Group3
arm group label: Group4
arm group label: Group5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hanan Omar Mohamed, Professor Doctor
phone: 01223971654
email: hannahomer@yahoo.com
last name: Eman Mohammed Salaheldin, Lecturer
phone: 01028030966
email: emansalah.eldin@yahoo.com
citation: Teng J, Sun F, Yu PF, Li JX, Yuan D, Chang J, Lin SH. Differential microRNA expression in the serum of patients with nephrotic syndrome and clinical correlation analysis. Int J Clin Exp Pathol. 2015 Jun 1;8(6):7282-6. eCollection 2015.
PMID: 26261628
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: RAMahmoud
investigator title: Principle investigator
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Syndrome