NCT05972408

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

July 25, 2023

Last Update Submit

June 6, 2024

Conditions

Keywords

renal calculi, Renal Ca oxalate stones, VDR gene

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Stone recurrence

    two years

Interventions

Endoscopic removal of renal stones

checking possible mutations of VDR and CASR genes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with unilateral or bilateral renal stones (de novo or recurrent) who were candidates for endoscopic or surgical intervention

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Outside U.S./Canada, 35561, Egypt

Location

Related 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.

    PMID: 27644547BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Receptors, CalcitriolReceptors, Calcium-Sensing

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Receptors, Cytoplasmic and NuclearProteinsAmino Acids, Peptides, and ProteinsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

March 21, 2021

Primary Completion

September 21, 2023

Study Completion

January 19, 2024

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations