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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05972408
Other study ID # MD.21.02.426
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 21, 2021
Est. completion date January 19, 2024

Study information

Verified date June 2024
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based stones among Patients with Renal Calcular Disease in Mansoura Urology and Nephrology Center


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date January 19, 2024
Est. primary completion date September 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 "a" 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
percutaneous nephrlolithotomy
Endoscopic removal of renal stones
Genetic:
VDR gene, CASR gene
checking possible mutations of VDR and CASR genes

Locations

Country Name City State
Egypt Mansoura University Mansoura Outside U.S./Canada

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of Ca-based renal stones Prevalence of Ca stones among patients with kidney stone disease admitted in Mansoura UNC throughout the study duration as assessed by infrared spectroscopic stone analysis two years
Primary Genetic background of Ca based renal stones Identification of metabolic derangement and genomic alterations in patients with renal Ca stones (CASR, and VDR genes) two years
Secondary Stone recurrence Evaluation of the possible correlation of detected genomic mutations assessed by genetic analysis with stone recurrence at 2 years following stone management. two years
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