Ureteric StoneNCT04759417
Comparison of CHOKAI vs STONE Score to Predict the Presence of Ureteric Stones in Patients With Renal Colic: A Multi-center Prospective Observational Study
An observational study of Ureteric Stone, run by Zayed Military Hospital at 3 sites in United Arab Emirates.
Trial summary
Background: The STONE score has traditionally been used as a clinical prediction tool to predict the presence of ureteric stones in patients presenting with renal colic. More recently, the CHOKAI score was introduced and found to have superior diagnostic accuracy on both internal and external validation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteric Stone
- How many people
- 92 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- 1 Feb 2021to 25 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to the Emergency Department with symptoms suspicious of urolithiasis
Who may be able to join
- Adult population (≥18 years of age) presenting to the Emergency Department with symptoms determined by the investigating ED Physician to be suspicious of urolithiasis (e.g. flank pain, lower abdominal pain, back pain and/or hematuria)
- Patients suspected to have ureteric stone who underwent CT scan to confirm diagnosis
Who cannot join
- Complicated ureteric colic:
- Abnormal vital signs - body temperature > 37.7 °C or systolic blood pressure ˂90 mmHg)
- Active malignancy
- Abnormal kidney function (abnormal levels of creatinine/BUN)
- Recent (within past 6 months) trauma or urologic surgery
- Age <18 years
- Pregnant patient
- Patient with incomplete interview/documentation data (e.g. missing US/CT/ UA)
Trial locations and contacts
3 sites in 1 country.
United Arab Emirates3 sites
Sheikh Shakhbout Medical City
Abu Dhabi
Tawam Hospital
Abu Dhabi
Zayed Military Hospital
Abu Dhabi
About this study
Official title: A Multi-center Prospective Observational Study to Evaluate and Compare Diagnostic Accuracy and Reliability of Variables of the CHOKAI and STONE Scores to Predict the Presence of Ureteric Stones as Confirmed on CT Scans
Background: The STONE score has traditionally been used as a clinical prediction tool to predict the presence of ureteric stones in patients presenting with renal colic. More recently, the CHOKAI score was introduced and found to have superior diagnostic accuracy on both internal and external validation.
Objective: Our study aims to externally validate and compare the use of both the CHOKAI and STONE score in a population of UAE patients presenting to the Emergency Department for renal colic.
Read more
Methods: Over a period of approximately 6 months, the study will follow Emergency Department Physicians at each institution and retrieve data from their encounters with patients presenting with renal colic. Parameters for both CHOKAI and STONE scores will be logged, extracted and matched against a reference standard of CT scan to compare diagnostic accuracy of both scores to predict the presence of ureteric stones in this population.
Goals: Evaluation of the findings will discern applicability of scores to the UAE population and contribute to reducing unnecessary radiation exposure.
To our knowledge, no studies have compared the use of these scores to diagnose urolithiasis in the United Arab Emirates. Furthermore, this will be the first study to externally validate the CHOKAI score outside of Japan using a controlled, prospective design.
Read the detailed description
Over a period of approximately 6 months, the study will follow Emergency Department Physicians at each of three separate institutions and retrieve data from their encounters with patients presenting with renal colic. Parameters for both CHOKAI and STONE scores will be logged, extracted and matched against a reference standard of CT scan to compare diagnostic accuracy of both scores to predict the presence of ureteric stones in this population
Full-time ED Physicians from each institution will be recruited to participate in the study as follows:
Each ED Physician shall be provided with Data Collection Sheet. This form will provide them with a standardized option to enter the components of the STONE and CHOKAI score using data normally conducted in the history taking and physical examination of patients suspected to have ureteric stones. Additional items have also been included to investigate for other variables that could influence clinical prediction of presence of ureteric stones.
Those patients suspected to have ureteric stones will have confirmation of urolithiasis by non-contrast CT scan. Though the investigators will log the data in their respective data collection sheets per patient, they will not be involved in entering this data onto the study's database.
Data will be collected for a period of approximately 6 months from February 1, 2021 onward, with a target sample size of 200 patients.
- Conditions
- Ureteric Stone
- Keywords
- ureteric stone, CHOKAI, STONE, UAE, renal colic
- Medical subject headings
- Ureterolithiasis, Renal Colic
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy comparison
Compare the diagnostic accuracies of the CHOKAI and STONE scores in predicting the presence of ureteric stones by using differences in the area under the curve (AUC) between the CHOKAI and STONE scores, calculated using Receiver Operating Characteristic (ROC) analysis
Measured: 6 months
Secondary outcomes (2)
Determine optimal cut-off point
Point on ROC analysis where maximum sensitivity and specificity exist. Calculate sensitivity, specificity, positive likelihood ratio and negative likelihood ratio at this point
Measured: 6 months
Rate of admission for patients
Frequency of admission disposition for patients, to evaluate for any association of high risk on predictor scores to admission dispositions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion31 Mar 2022
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric 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
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zayed Military Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammad Anzal Rehman, Zayed Military Hospital
- Investigators
- Mohammad Anzal Rehman, MD, Principal investigator, Zayed Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759417
- Sponsor's protocol ID
- SEHA-019
- Status last verified
- Jul 2024
- First submitted
- 3 Feb 2021
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol for selection of patients used for prospective data collection shall be made available for the entirety of the study duration, including the Informed Consent Form we will use during patient encounters. The Statistical Analysis Plan (SAP) will be shared after results are compiled (approximately in 6 months from study start date) and processed by the biostatistician for a period of 3 months
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Observational Study to Evaluate and Compare Diagnostic Accuracy and Reliability of Variables of the CHOKAI and STONE Scores to Predict the Presence of Ureteric Stones as Confirmed on CT Scans
- ClinicalTrials.gov ID
- NCT04759417
- Acronym / sponsor ID
- SEHA-019
- Conditions
- Ureteric Stone
- Keywords
- ureteric stone, CHOKAI, STONE, UAE, renal colic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Zayed Military HospitalOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 18 Feb 2021 (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.
Background: The STONE score has traditionally been used as a clinical prediction tool to predict the presence of ureteric stones in patients presenting with renal colic. More recently, the CHOKAI score was introduced and found to have superior diagnostic accuracy on both internal and external validation.
Objective: Our study aims to externally validate and compare the use of both the CHOKAI and STONE score in a population of UAE patients presenting to the Emergency Department for renal colic.
Methods: Over a period of approximately 6 months, the study will follow Emergency Department Physicians at each institution and retrieve data from their encounters with patients presenting with renal colic. Parameters for both CHOKAI and STONE scores will be logged, extracted and matched against a reference standard of CT scan to compare diagnostic accuracy of both scores to predict the presence of ureteric stones in this population.
Goals: Evaluation of the findings will discern applicability of scores to the UAE population and contribute to reducing unnecessary radiation exposure.
To our knowledge, no studies have compared the use of these scores to diagnose urolithiasis in the United Arab Emirates. Furthermore, this will be the first study to externally validate the CHOKAI score outside of Japan using a controlled, prospective design.
Detailed description
Over a period of approximately 6 months, the study will follow Emergency Department Physicians at each of three separate institutions and retrieve data from their encounters with patients presenting with renal colic. Parameters for both CHOKAI and STONE scores will be logged, extracted and matched against a reference standard of CT scan to compare diagnostic accuracy of both scores to predict the presence of ureteric stones in this population
Full-time ED Physicians from each institution will be recruited to participate in the study as follows:
Each ED Physician shall be provided with Data Collection Sheet. This form will provide them with a standardized option to enter the components of the STONE and CHOKAI score using data normally conducted in the history taking and physical examination of patients suspected to have ureteric stones. Additional items have also been included to investigate for other variables that could influence clinical prediction of presence of ureteric stones.
Those patients suspected to have ureteric stones will have confirmation of urolithiasis by non-contrast CT scan. Though the investigators will log the data in their respective data collection sheets per patient, they will not be involved in entering this data onto the study's database.
Data will be collected for a period of approximately 6 months from February 1, 2021 onward, with a target sample size of 200 patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the Emergency Department with symptoms suspicious of urolithiasis
Key inclusion criteria (2 listed)
- Adult population (≥18 years of age) presenting to the Emergency Department with symptoms determined by the investigating ED Physician to be suspicious of urolithiasis (e.g. flank pain, lower abdominal pain, back pain and/or hematuria)
- Patients suspected to have ureteric stone who underwent CT scan to confirm diagnosis
Key exclusion criteria (8 listed)
- Abnormal vital signs - body temperature > 37.7 °C or systolic blood pressure ˂90 mmHg)
- Active malignancy
- Abnormal kidney function (abnormal levels of creatinine/BUN)
- Recent (within past 6 months) trauma or urologic surgery
- Age <18 years
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
Diagnostic accuracy comparison
Time frame: 6 months
Compare the diagnostic accuracies of the CHOKAI and STONE scores in predicting the presence of ureteric stones by using differences in the area under the curve (AUC) between the CHOKAI and STONE scores, calculated using Receiver Operating Characteristic (ROC) analysis
2 secondary outcomes
Determine optimal cut-off point
Time frame: 6 months
Rate of admission for patients
Time frame: 6 months
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 29 Jul 2024.
- Individual participant dataSharing planned: Yes. The protocol for selection of patients used for prospective data collection shall be made available for the entirety of the study duration, including the Informed Consent Form we will use during patient encounters. The Statistical Analysis Plan (SAP) will be shared after results are compiled (approximately in 6 months from study start date) and processed by the biostatistician for a period of 3 months
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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.
Mohammad Anzal Rehman, MD principal investigator
Zayed Military Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteric Stone, run by Zayed Military Hospital at 3 sites in United Arab Emirates.
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 2 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: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Arab Emirates. 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?
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?
Diagnostic accuracy comparison (time frame: 6 months). 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 29 Jul 2024.