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CompletedNCT06992206Kidney stoneUpdated May 28, 2025

What Lies Beneath the Stone? Metabolic Insights From Composition-Based Analysis of Kidney Stones

An observational study in Urolithiasis, Calcium Oxalate, sponsored by Hisar Intercontinental Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Hisar Intercontinental Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
506
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

This retrospective study aims to evaluate the metabolic characteristics of patients with urolithiasis based on kidney stone composition. Data were collected from patients treated for kidney stones between January 2010 and December 2024 at a tertiary urology center. Stone analysis was performed using FTIR spectroscopy, classifying stones into subtypes including calcium oxalate monohydrate (COM), calcium oxalate dihydrate (COD), uric acid, and mixed types.

Serum levels of calcium, phosphorus, uric acid, creatinine, and parathyroid hormone (PTH), along with 24-hour urine values (calcium, oxalate, citrate, uric acid, volume, and pH), were recorded. The study primarily compares metabolic differences between:

First-time vs. recurrent stone formers

COM vs. COD stone subtypes

Findings from this study are expected to improve understanding of metabolic risk factors and contribute to the development of tailored metabolic evaluations and dietary or pharmacological preventive strategies for recurrent stone formers.

02

Conditions studied

  • Urolithiasis, Calcium Oxalate

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Keywords

  • Calcium oxalate
  • Metabolic evaluation
  • Urolithiasis
  • Stone composition
03

In context

Urolithiasis

253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.

This study's enrollment of 506 is above the median of 150 across 65 observational studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Hisar Intercontinental Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
506 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherMetabolik taş analizi ile retrospektif gözlem

    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

06

What researchers measure

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.

    Time frame: January 2010 and December 2024

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — 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).

Supporting information: Study protocol, Statistical analysis plan, 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2010 to primary completion in Dec 2024, 179 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2025
First posted
May 28, 2025
StartActual
Jan 1, 2010
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
May 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06992206
Lead sponsor
Hisar Intercontinental Hospital
Responsible party
Basri Cakiroglu (Prof.Dr, Hisar Intercontinental Hospital) — Principal investigator
First posted
May 28, 2025
Start date
Jan 1, 2010
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
May 28, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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