Back to resultsEvaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based Stones Among Patients With Renal Calcular Disease in Mansoura Urology and Nephrology Center
Primary Purpose
Renal Calculi
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
percutaneous nephrlolithotomy
VDR gene, CASR gene
Sponsored by
About this trial
This is an interventional screening trial for Renal Calculi focused on measuring renal calculi, Renal Ca oxalate stones, VDR gene
Eligibility Criteria
Inclusion Criteria: All patients with unilateral or bilateral renal stones (de novo or recurrent) who were candidates for endoscopic or surgical intervention were included. Metabolic workup was done for selected patients with radio-opaque stones, while genetic testing was done for those with dominant Ca composition proven by postoperative stone analysis. Thirty healthy individuals with no urologic abnormalities were involved as control cases. Patients with renal calculi for whom metabolic and genetic testing were performed are designated "α" cases. Exclusion Criteria: For metabolic and genetic testing, patients with a well-known lesion precipitating stone disease were excluded e.g. ureteric stricture, ureteropelvic or ureterovesical junction obstruction, urinary diversion, history of ureterovesical re-implantation as well as patients with non-Ca stones by post-operative stone analysis
Sites / Locations
- Mansoura UniversityRecruiting
Outcomes
Primary Outcome Measures
prevalence of Ca-based renal stones
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)
Secondary Outcome Measures
Stone recurrence
Evaluation of the possible correlation of detected genomic mutations with stone recurrence at 2 years following stone management.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05972408
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based stones among Patients with Renal Calcular Disease in Mansoura Urology and Nephrology Center
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi
Keywords
renal calculi, Renal Ca oxalate stones, VDR gene
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
PCNL for patients with radio-opaque renal stones
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
percutaneous nephrlolithotomy
Intervention Description
Endoscopic removal of renal stones
Intervention Type
Genetic
Intervention Name(s)
VDR gene, CASR gene
Intervention Description
checking possible mutations of VDR and CASR genes
Primary Outcome Measure Information:
Title
prevalence of Ca-based renal stones
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)
Time Frame
two years
Secondary Outcome Measure Information:
Title
Stone recurrence
Description
Evaluation of the possible correlation of detected genomic mutations with stone recurrence at 2 years following stone management.
Time Frame
two years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients with unilateral or bilateral renal stones (de novo or recurrent) who were candidates for endoscopic or surgical intervention were included. Metabolic workup was done for selected patients with radio-opaque stones, while genetic testing was done for those with dominant Ca composition proven by postoperative stone analysis. Thirty healthy individuals with no urologic abnormalities were involved as control cases. Patients with renal calculi for whom metabolic and genetic testing were performed are designated "α" cases.
Exclusion Criteria:
For metabolic and genetic testing, patients with a well-known lesion precipitating stone disease were excluded e.g. ureteric stricture, ureteropelvic or ureterovesical junction obstruction, urinary diversion, history of ureterovesical re-implantation as well as patients with non-Ca stones by post-operative stone analysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elhussein Abolazm, MsC
Phone
+20502202222
Email
ahmedelhussein@mans.edu.eg
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Outside U.S./Canada
ZIP/Postal Code
35561
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansoura Urology and Nephrology center
Phone
+20502202222
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27644547
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.
Results Reference
background
Learn more about this trial
Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based Stones Among Patients With Renal Calcular Disease in Mansoura Urology and Nephrology Center
We'll reach out to this number within 24 hrs