Urinary StoneNCT02949323
Etiological Diagnosis of Urinary Stone in Chinese Children
An observational study of Urinary Stone, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The incidence of nephrolithiasis in children has been reported to increase by approximately 6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent rate. Investigators aimed to determine the metabolic risk factors in Chinese children through metabolic evaluation. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Stone
- What is being tested?
- urinary stone
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2019
- 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 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with urinary stones
Who may be able to join
- Children with urinary stones
Who cannot join
- Anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature >38°C and/or positive urine culture), solitary kidney, and renal insufficiency
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Hongquan geng, M.D, +86-13801973493, ghongquan@hotmail.com
Lei He, M.D, +86-13918845298, lyghelei@163.com
About this study
The incidence of nephrolithiasis in children has been reported to increase by approximately 6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent rate. Investigators aimed to determine the metabolic risk factors in Chinese children through metabolic evaluation.
In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.
Read the detailed description
Investigators aimed to determine the metabolic risk factors in 200 Chinese children with urinary stones through metabolic evaluation.
In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.
- Conditions
- Urinary Stone
- Being tested
- urinary stone
- Keywords
- children, renal stone, metabolic evaluation, Mutational analysis
- Medical subject headings
- Urinary Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary stoneOther
patients of group one have urinary stones
| Study group | Role | What they receive |
|---|---|---|
| children with urinary stones | children with urinary stones Receives: Other: urinary stone | |
| children without urinary stones | children without urinary stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary oxalate;
Measured: urine collected in 24 hours
Secondary outcomes (2)
Urinary citrate;
Measured: urine collected in 24 hours
Urinary calcium
Measured: urine collected in 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongquan Geng, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hongquan Geng, M.D, Study chair, Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineLei He, M.D, Principal investigator, Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949323
- Sponsor's protocol ID
- XH-16-026
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiological Diagnosis of Urinary Stone in Chinese Children
- ClinicalTrials.gov ID
- NCT02949323
- Acronym / sponsor ID
- XH-16-026
- Conditions
- Urinary Stone
- Keywords
- children, renal stone, metabolic evaluation, Mutational analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- 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.
The incidence of nephrolithiasis in children has been reported to increase by approximately 6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent rate. Investigators aimed to determine the metabolic risk factors in Chinese children through metabolic evaluation.
In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.
Detailed description
Investigators aimed to determine the metabolic risk factors in 200 Chinese children with urinary stones through metabolic evaluation.
In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with urinary stones | – | Other: urinary stonechildren with urinary stones |
| children without urinary stones | – | –children without urinary stones |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with urinary stones
Key inclusion criteria (1 listed)
- Children with urinary stones
Key exclusion criteria (1 listed)
- Anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature >38°C and/or positive urine culture), solitary kidney, and renal insufficiency
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 |
|---|---|---|
| urinary stonepatients of group one have urinary stones | Other | children with urinary stones |
Primary outcome
Urinary oxalate;
Time frame: urine collected in 24 hours
2 secondary outcomes
Urinary citrate;
Time frame: urine collected in 24 hours
Urinary calcium
Time frame: urine collected in 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: No. no plan
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Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
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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.
Hongquan Geng, M.D study chair
Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lei He, M.D principal investigator
Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongquan Geng, M.D (+86-13801973493, ghongquan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary oxalate; (time frame: urine collected in 24 hours). 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 31 Oct 2016.