NCT05634434

Brief Summary

  • Reporting prevalence of uric acid based renal stones among patients with nephrolithiasis admitted to Mansoura Urology and Nephrology center (MUNC).
  • Furthermore, identification of monogenic and polygenic uric acid stone formers.
  • Identification of factors associated uric acid stone recurrence as well as determinants of laterality in patients with uric acid based renal stones

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

November 22, 2022

Last Update Submit

November 22, 2022

Conditions

Keywords

kidney stonesuric acid

Outcome Measures

Primary Outcomes (1)

  • reporting overall prevalence of uric acid stones

    reporting overall prevalence of uric acid stones among patients with renal stones admitted in Mansoura UNC during study period.

    1 year

Secondary Outcomes (1)

  • identification of genetic alterations in patients with uric acid stones

    1year

Study Arms (2)

control group

Same patient, stone free kidney

Study group

uric acid stone former, diseased kidney (stone harboring)

Eligibility Criteria

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

Uric acid-based renal stone formers * Denovo uric acid stone former (DUASF) * Recurrent uric acid stone former (RUASF)

You may qualify if:

  • ⦁ Patients with unilateral renal stones (denovo or recurrent) who are candidates for endoscopic treatment (percutaneous nephrolithotomy).
  • Patients with preoperative NCCT findings of renal stone with stone density equal or less than 600HU.
  • Patients with dominant uric acid composition will be included as proven by postoperative stone analysis

You may not qualify if:

  • ⦁ Patients with anatomical abnormalities precipitating stone disease e.g. ureteric stricture, ureteropelvic or ureterovesical junction obstruction, Urinary diversion, History of ureterovesical re-implantation
  • Patients with non-uric acid stones as proven by post-operative stone analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine samples were collected from the renal pelvis of the kidney using ureteric catheter

MeSH Terms

Conditions

NephrolithiasisUrinary CalculiKidney Calculi

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Elshal, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed M elshal, PHD

CONTACT

Islam M hawash, MD student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 2, 2022

Study Start

October 1, 2021

Primary Completion

December 30, 2022

Study Completion

October 1, 2023

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations