Urinary StoneNCT07736924
2D:4D Digit Ratio and Urinary Stone Disease
An observational study of Urinary Stone, run by Emrah Kızılay at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational case-control study will investigate whether the 2D:4D digit ratio is associated with urinary stone disease. Adults undergoing non-contrast computed tomography at Malatya Training and Research Hospital will be classified as cases if kidney and/or ureteral stones are detected and as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Stone
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of consecutive adults undergoing non-contrast computed tomography at Malatya Training and Research Hospital during the study period. Participants with kidney and/or ureteral stones will constitute the case group. Participants without urinary stones on computed tomography and without a previous history of urinary stone disease or stone surgery will constitute the control group.
Who may be able to join
- Age 18 years or older
- Provision of written informed consent
- Undergoing non-contrast computed tomography at Malatya Training and Research Hospital during the study period
- For cases: presence of at least one kidney and/or ureteral stone on non-contrast computed tomography
- For controls: absence of stones in the kidneys, ureters, and bladder on non-contrast computed tomography
- For controls: no previous physician-diagnosed urinary stone disease or history of stone-related surgery
- Feasibility of bilateral second- and fourth-digit length measurements
Who cannot join
- Congenital deformity of the hands or fingers
- History of hand or finger trauma, fracture, surgery, or amputation that may affect digit length measurement
- Severe hand deformity, contracture, or advanced joint disease preventing reliable measurement
- Incomplete, inadequate, or technically unreliable 2D:4D measurements
- Missing essential clinical, demographic, or imaging data
- Pregnancy
- Presence of bladder stones
- Urinary diversion, major urinary tract reconstruction, or a significant structural urinary tract anomaly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital
Malatya, Malatya, 44000
Emrah KIZILAY, MD, +905363887322, emrahkizilay@hotmail.com
About this study
Official title: Association Between 2D:4D Digit Ratio and Urinary Stone Disease: A Prospective Observational Case-Control Study
This prospective observational case-control study will investigate whether the 2D:4D digit ratio is associated with urinary stone disease. Adults undergoing non-contrast computed tomography at Malatya Training and Research Hospital will be classified as cases if kidney and/or ureteral stones are detected and as controls if no urinary stones are detected and there is no previous history of stone disease or stone surgery. The lengths of the second and fourth fingers of both hands will be measured using a digital caliper by two independent observers who are blinded to the participant group. The study will also examine whether the 2D:4D ratio is associated with recurrent stone disease, stone burden, and bilateral or multiple stones.
- Conditions
- Urinary Stone
- Keywords
- 2D:4D Digit Ratio, Urolithiasis, Kidney Stones, Urinary Stones, Prenatal Androgen Exposure
- Medical subject headings
- Urinary Calculi, Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Stone Disease Group | Adults with kidney and/or ureteral stones detected on non-contrast computed tomography. | |
| Stone-Free Control Group | Adults with no urinary stones detected in the kidneys, ureters, or bladder on non-contrast computed tomography and with no previous physician-diagnosed urinary stone disease or history of stone surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Bilateral 2D:4D Digit Ratio by Urinary Stone Disease Status
The lengths of the second and fourth digits of both hands will be measured using a digital caliper by two independent observers blinded to group status. Right and left 2D:4D ratios will be calculated by dividing the length of the second digit by the length of the fourth digit. The mean bilateral 2D:4D ratio will be calculated as the average of the right and left ratios and compared between participants with computed tomography-confirmed kidney and/or ureteral stones and stone-free controls.
Measured: At enrollment, during the single study assessment
Secondary outcomes (3)
Mean Bilateral 2D:4D Digit Ratio by Recurrent Stone Disease Status
Among participants with computed tomography-confirmed kidney and/or ureteral stones, recurrent stone disease will be defined as at least one previous physician-diagnosed urinary stone episode, spontaneous stone passage, or stone-related surgical intervention before the current stone episode. The mean bilateral 2D:4D ratio will be compared between participants with recurrent stone disease and those experiencing their first documented stone episode.
Measured: At enrollment, during the single study assessment
Association Between Mean Bilateral 2D:4D Digit Ratio and Total Stone Burden
Among participants with computed tomography-confirmed kidney and/or ureteral stones, total stone burden will be calculated as the sum of the maximum diameters of all detected stones in millimeters on non-contrast computed tomography. The association between mean bilateral 2D:4D ratio and total stone burden will be evaluated.
Measured: At enrollment, during the single study assessment
Mean Bilateral 2D:4D Digit Ratio by Bilateral and/or Multiple Stone Presentation
Among participants with computed tomography-confirmed kidney and/or ureteral stones, bilateral stone disease will be defined as the presence of stones on both sides of the urinary tract, and multiple stone disease will be defined as the presence of two or more distinct stones. The mean bilateral 2D:4D ratio will be compared between participants with bilateral and/or multiple stones and those with a solitary unilateral stone.
Measured: At enrollment, during the single study assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary StoneStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emrah Kızılay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emrah Kızılay, Malatya Governor Research Hospital
- Investigators
- Emrah KIZILAY, Principal investigator, Malatya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736924
- Sponsor's protocol ID
- MEAH-2D4D-USD-2026-01
- Other IDs
- SBBA-2026-252
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share de-identified individual participant data has not yet been finalized. Any future data sharing will depend on ethics committee approval, participant consent, applicable data protection requirements, and the establishment of an appropriate controlled-access process.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between 2D:4D Digit Ratio and Urinary Stone Disease: A Prospective Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT07736924
- Acronym / sponsor ID
- MEAH-2D4D-USD-2026-01
- Conditions
- Urinary Stone
- Keywords
- 2D:4D Digit Ratio, Urolithiasis, Kidney Stones, Urinary Stones, Prenatal Androgen Exposure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emrah KızılayUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 30 Jul 2026 (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 prospective observational case-control study will investigate whether the 2D:4D digit ratio is associated with urinary stone disease. Adults undergoing non-contrast computed tomography at Malatya Training and Research Hospital will be classified as cases if kidney and/or ureteral stones are detected and as controls if no urinary stones are detected and there is no previous history of stone disease or stone surgery. The lengths of the second and fourth fingers of both hands will be measured using a digital caliper by two independent observers who are blinded to the participant group. The study will also examine whether the 2D:4D ratio is associated with recurrent stone disease, stone burden, and bilateral or multiple stones.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary Stone Disease Group | – | –Adults with kidney and/or ureteral stones detected on non-contrast computed tomography. |
| Stone-Free Control Group | – | –Adults with no urinary stones detected in the kidneys, ureters, or bladder on non-contrast computed tomography and with no previous physician-diagnosed urinary stone disease or history of stone surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of consecutive adults undergoing non-contrast computed tomography at Malatya Training and Research Hospital during the study period. Participants with kidney and/or ureteral stones will constitute the case group. Participants without urinary stones on computed tomography and without a previous history of urinary stone disease or stone surgery will constitute the control group.
Key inclusion criteria (7 listed)
- Age 18 years or older
- Provision of written informed consent
- Undergoing non-contrast computed tomography at Malatya Training and Research Hospital during the study period
- For cases: presence of at least one kidney and/or ureteral stone on non-contrast computed tomography
- For controls: absence of stones in the kidneys, ureters, and bladder on non-contrast computed tomography
Key exclusion criteria (8 listed)
- Congenital deformity of the hands or fingers
- History of hand or finger trauma, fracture, surgery, or amputation that may affect digit length measurement
- Severe hand deformity, contracture, or advanced joint disease preventing reliable measurement
- Incomplete, inadequate, or technically unreliable 2D:4D measurements
- Missing essential clinical, demographic, or imaging data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Bilateral 2D:4D Digit Ratio by Urinary Stone Disease Status
Time frame: At enrollment, during the single study assessment
The lengths of the second and fourth digits of both hands will be measured using a digital caliper by two independent observers blinded to group status. Right and left 2D:4D ratios will be calculated by dividing the length of the second digit by the length of the fourth digit. The mean bilateral 2D:4D ratio will be calculated as the average of the right and left ratios and compared between participants with computed tomography-confirmed kidney and/or ureteral stones and stone-free controls.
3 secondary outcomes
Mean Bilateral 2D:4D Digit Ratio by Recurrent Stone Disease Status
Time frame: At enrollment, during the single study assessment
Association Between Mean Bilateral 2D:4D Digit Ratio and Total Stone Burden
Time frame: At enrollment, during the single study assessment
Mean Bilateral 2D:4D Digit Ratio by Bilateral and/or Multiple Stone Presentation
Time frame: At enrollment, during the single study assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided. The decision to share de-identified individual participant data has not yet been finalized. Any future data sharing will depend on ethics committee approval, participant consent, applicable data protection requirements, and the establishment of an appropriate controlled-access process.
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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.
Emrah KIZILAY principal investigator
Malatya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Stone, run by Emrah Kızılay at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emrah KIZILAY, MD (+905363887322, emrahkizilay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Bilateral 2D:4D Digit Ratio by Urinary Stone Disease Status (time frame: At enrollment, during the single study assessment). 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 30 Jul 2026.