NCT06992206

Brief Summary

This retrospective observational study investigates the metabolic abnormalities associated with different types of kidney stones by analyzing their composition. The study includes adult patients diagnosed with urolithiasis, whose stone samples were analyzed using Fourier Transform Infrared (FTIR) spectroscopy. Clinical, biochemical, and 24-hour urine metabolic parameters were compared between first-time and recurrent stone formers, and among subtypes of calcium oxalate stones (monohydrate vs. dihydrate). The goal is to identify metabolic risk factors that contribute to stone formation and recurrence, and to provide insights for individualized prevention strategies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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

January 1, 2010

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

15 years

First QC Date

May 18, 2025

Last Update Submit

May 24, 2025

Conditions

Keywords

Calcium oxalateMetabolic evaluationUrolithiasisStone composition

Outcome Measures

Primary Outcomes (1)

  • Kalsiyum oksalat taşı tipine göre serum ve 24 saatlik idrar parametrelerinin dağılımı Zaman Çerçevesi (Time Frame): 01 Ocak 2010 - 31 Aralık 2024 tarihleri arasında toplanan hasta verileri

    FTIR spektroskopisi ile taş bileşimi belirlenen hastalar arasında, kalsiyum oksalat monohidrat (COM) ve dihidrat (COD) taşı olan bireylerin metabolik parametreleri (serum kalsiyum, fosfor, magnezyum, parathormon; 24 saatlik idrarla kalsiyum, oksalat, sitrat, pH, Na, ürik asit vb.) retrospektif olarak analiz edilmiştir.

    January 2010 and December 2024

Study Arms (2)

First-time Stone Formers

Adult patients who presented with their first episode of kidney stone disease. These patients underwent stone composition analysis via FTIR spectroscopy and metabolic evaluation including serum and 24-hour urine testing to identify risk factors for initial stone formation.

Other: Metabolik taş analizi ile retrospektif gözlem

Recurrent Stone Formers

Patients with a documented history of recurrent kidney stone episodes. These individuals were evaluated to assess differences in metabolic profiles and stone composition compared to first-time stone formers, with the aim of identifying predictors of recurrence and optimizing preventive strategies.

Other: Metabolik taş analizi ile retrospektif gözlem

Interventions

This study did not involve an active intervention. It retrospectively analyzed medical records of 506 patients who underwent compositional analysis of kidney stones to identify metabolic abnormalities. The aim was to evaluate stone composition in relation to metabolic parameters such as serum and 24-hour urine values, without modifying patient treatment.

Also known as: Böbrek taşı kompozisyonu değerlendirmesi Retrospektif metabolik değerlendirme
First-time Stone FormersRecurrent Stone Formers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study included 506 patients who presented with nephrolithiasis and underwent metabolic evaluation of stone composition. Data were collected retrospectively from medical records at Hisar Intercontinental Hospital between 2010 and 2024.

You may qualify if:

  • Age ≥ 18 years
  • Patients diagnosed with kidney stones between January 2010 and December 2024
  • Stone composition analyzed via Fourier-transform infrared (FTIR) spectroscopy
  • Available metabolic panel including serum and 24-hour urine values

You may not qualify if:

  • Patients with secondary hyperparathyroidism, renal tubular acidosis, or other systemic metabolic diseases affecting stone formation
  • Patients with incomplete medical records
  • Patients with non-calcium-based stones (e.g., uric acid, struvite, cystine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nephrolithiasis, Calcium OxalateUrolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 28, 2025

Study Start

January 1, 2010

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) to be shared include stone composition types (e.g., calcium oxalate monohydrate vs dihydrate), serum metabolic parameters (e.g., calcium, phosphorus, PTH), and 24-hour urine findings (e.g., oxalate, citrate, pH, sodium, uric acid).

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be made available 6 months after publication of the main study results and will remain accessible for a period of 36 months upon request.
Access Criteria
Qualified researchers affiliated with academic or healthcare institutions may request access to the de-identified IPD for secondary analysis or meta-analysis. Requests should be submitted to the corresponding author with a detailed research proposal. Data access will be granted following review and under a data-sharing agreement.