Urolithiasis, Calcium OxalateKidney stoneNCT06992206
What Lies Beneath the Stone? Metabolic Insights From Composition-Based Analysis of Kidney Stones
An observational study of Urolithiasis, Calcium Oxalate, run by Hisar Intercontinental Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis, Calcium Oxalate
- What is being tested?
- Metabolik taş analizi ile retrospektif gözlem
- How many people
- 506 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: What Lies Beneath the Stone? Metabolic Insights From Composition-based Analysis of Kidney Stones
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.
- Conditions
- Urolithiasis, Calcium Oxalate
- Being tested
- Metabolik taş analizi ile retrospektif gözlem
- Keywords
- Calcium oxalate, Metabolic evaluation, Urolithiasis, Stone composition
- Medical subject headings
- Nephrolithiasis, Calcium Oxalate, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolik taş analizi ile retrospektif gözlemOther
Also called Böbrek taşı kompozisyonu değerlendirmesi Retrospektif metabolik değerlendirme
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Metabolik taş analizi ile retrospektif gözlem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 2010 and December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urolithiasis, Calcium OxalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992206
- Sponsor's protocol ID
- Hisar-KSD-2025-33
- Acronym
- Kidney stone
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Lies Beneath the Stone? Metabolic Insights From Composition-based Analysis of Kidney Stones
- ClinicalTrials.gov ID
- NCT06992206
- Acronym / sponsor ID
- Kidney stone / Hisar-KSD-2025-33
- Conditions
- Urolithiasis, Calcium Oxalate
- Keywords
- Calcium oxalate, Metabolic evaluation, Urolithiasis, Stone composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-time Stone Formers | – | Other: Metabolik taş analizi ile retrospektif gözlemAdult 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. |
| Recurrent Stone Formers | – | Other: Metabolik taş analizi ile retrospektif gözlemPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolik taş analizi ile retrospektif gözlemAlso: Böbrek taşı kompozisyonu değerlendirmesi Retrospektif metabolik değerlendirmeThis 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. | Other | First-time Stone Formers, Recurrent Stone Formers |
Primary outcome
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
Time frame: January 2010 and December 2024
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, Calcium Oxalate, run by Hisar Intercontinental Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: January 2010 and December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.