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/NCT05972408</url>
    </required_header>
    <id_info>
      <org_study_id>MD.21.02.426</org_study_id>
      <nct_id>NCT05972408</nct_id>
    </id_info>
    <brief_title>Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based Stones Among Patients With Renal Calcular Disease in Mansoura Urology and Nephrology Center</brief_title>
    <official_title>Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based Stones Among Patients With Renal Calcular Disease in Mansoura Urology and Nephrology Center</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura 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>
        Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based stones among&#xD;
        Patients with Renal Calcular Disease in Mansoura Urology and Nephrology Center&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Back ground: Nephrolithiasis is a prevalent disease with high morbidity, the incidence and&#xD;
        prevalence of nephrolithiasis has risen worldwide. Calcium nephrolithiasis may be considered&#xD;
        as a complex disease having multiple pathogenic mechanisms and characterized by various&#xD;
        clinical manifestations. Both genetic and environmental factors may increase susceptibility&#xD;
        to calcium stones. Polymorphisms of vitamin D receptor (VDR), calcium-sensing receptor gene&#xD;
        (CASR) and AGXT have been associated with risk of urolithiasis, but, with inconsistent&#xD;
        results and lack data from Egyptian population.&#xD;
  &#xD;
        Objective: Therefore, the present study aims to investigate the prevalence, mutational&#xD;
        profile for these genes in patients with Ca-based stones, admitted to Mansoura Urology and&#xD;
        Nephrology Center.&#xD;
  &#xD;
        Methodology: In this study, employing sequencing of the coding exons of the calcium-sensing&#xD;
        receptor gene (CASR), vitamin D receptor (VDR) and AGXT for a 50 of Egyptian calcium kidney&#xD;
        stone-formers and 20 control subjects. The results of the mutational profile data will be&#xD;
        correlated with risk of stone recurrence over 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2021</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>PCNL for patients with radio-opaque renal stones</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>prevalence of Ca-based renal stones</measure>
      <time_frame>two years</time_frame>
      <description>Prevalence of Ca stones among patients with kidney stone disease admitted in Mansoura UNC throughout the study duration.&#xD;
  Identification of metabolic derangement and genomic alterations in patients with renal Ca stones (CASR, and VDR genes)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stone recurrence</measure>
      <time_frame>two years</time_frame>
      <description>Evaluation of the possible correlation of detected genomic mutations with stone recurrence at 2 years following stone management.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Renal Calculi</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>percutaneous nephrlolithotomy</intervention_name>
      <description>Endoscopic removal of renal stones</description>
    </intervention>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>VDR gene, CASR gene</intervention_name>
      <description>checking possible mutations of VDR and CASR genes</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients with unilateral or bilateral renal stones (de novo or recurrent) who were&#xD;
               candidates for endoscopic or surgical intervention were included. Metabolic workup was&#xD;
               done for selected patients with radio-opaque stones, while genetic testing was done&#xD;
               for those with dominant Ca composition proven by postoperative stone analysis. Thirty&#xD;
               healthy individuals with no urologic abnormalities were involved as control cases.&#xD;
               Patients with renal calculi for whom metabolic and genetic testing were performed are&#xD;
               designated &quot;α&quot; cases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For metabolic and genetic testing, patients with a well-known lesion precipitating&#xD;
               stone disease were excluded e.g. ureteric stricture, ureteropelvic or ureterovesical&#xD;
               junction obstruction, urinary diversion, history of ureterovesical re-implantation as&#xD;
               well as patients with non-Ca stones by post-operative stone analysis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahmed Elhussein Abolazm, MsC</last_name>
      <phone>+20502202222</phone>
      <email>ahmedelhussein@mans.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mansoura University</name>
        <address>
          <city>Mansoura</city>
          <state>Outside U.S./Canada</state>
          <zip>35561</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mansoura Urology and Nephrology center</last_name>
        <phone>+20502202222</phone>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Wang C, Lu J, Lang Y, Liu T, Wang X, Zhao X, Shao L. Two novel AGXT mutations identified in primary hyperoxaluria type-1 and distinct morphological and structural difference in kidney stones. Sci Rep. 2016 Sep 20;6:33652. doi: 10.1038/srep33652.</citation>
      <PMID>27644547</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University</investigator_affiliation>
      <investigator_full_name>Ahmed Abolazm</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>renal calculi, Renal Ca oxalate stones, VDR gene</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Calculi</mesh_term>
      <mesh_term>Nephrolithiasis</mesh_term>
      <mesh_term>Calculi</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/NCT05972408
  org study id: MD.21.02.426
  nct id: NCT05972408
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based stones among
        Patients with Renal Calcular Disease in Mansoura Urology and Nephrology Center
  Back ground: Nephrolithiasis is a prevalent disease with high morbidity, the incidence and
        prevalence of nephrolithiasis has risen worldwide. Calcium nephrolithiasis may be considered
        as a complex disease having multiple pathogenic mechanisms and characterized by various
        clinical manifestations. Both genetic and environmental factors may increase susceptibility
        to calcium stones. Polymorphisms of vitamin D receptor (VDR), calcium-sensing receptor gene
        (CASR) and AGXT have been associated with risk of urolithiasis, but, with inconsistent
        results and lack data from Egyptian population.
  
        Objective: Therefore, the present study aims to investigate the prevalence, mutational
        profile for these genes in patients with Ca-based stones, admitted to Mansoura Urology and
        Nephrology Center.
  
        Methodology: In this study, employing sequencing of the coding exons of the calcium-sensing
        receptor gene (CASR), vitamin D receptor (VDR) and AGXT for a 50 of Egyptian calcium kidney
        stone-formers and 20 control subjects. The results of the mutational profile data will be
        correlated with risk of stone recurrence over 2 years.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention model description: PCNL for patients with radio-opaque renal stones
  primary purpose: Screening
  masking: None (Open Label)
  measure: prevalence of Ca-based renal stones
  time frame: two years
  description: Prevalence of Ca stones among patients with kidney stone disease admitted in Mansoura UNC throughout the study duration.
  Identification of metabolic derangement and genomic alterations in patients with renal Ca stones (CASR, and VDR genes)
  measure: Stone recurrence
  time frame: two years
  description: Evaluation of the possible correlation of detected genomic mutations with stone recurrence at 2 years following stone management.
  intervention type: Procedure
  intervention name: percutaneous nephrlolithotomy
  description: Endoscopic removal of renal stones
  intervention type: Genetic
  intervention name: VDR gene, CASR gene
  description: checking possible mutations of VDR and CASR genes
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed Elhussein Abolazm, MsC
  phone: +20502202222
  email: ahmedelhussein@mans.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Wang C, Lu J, Lang Y, Liu T, Wang X, Zhao X, Shao L. Two novel AGXT mutations identified in primary hyperoxaluria type-1 and distinct morphological and structural difference in kidney stones. Sci Rep. 2016 Sep 20;6:33652. doi: 10.1038/srep33652.
  PMID: 27644547
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University
  investigator full name: Ahmed Abolazm
  investigator title: MD
  mesh term: Kidney Calculi
  mesh term: Nephrolithiasis
  mesh term: Calculi
  sharing ipd: No