Urinary CalculiNCT01973088
Screening and Identification of Human Urate Transporter hURAT1 MicroRNA
An observational study of Urinary Calculi, run by Qian-wei Li.
Trial summary
This study intends to use in patients with renal tissue and blood samples, screening and identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further study of uric acid stone formation mechanism and the occurrence of clinical preventive uric acid stones provide new clues and new… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urinary Calculi
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jun 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Experiment are divided into uric acid stones group (A), non-uric acid stones group (B), control group (C), A, C recruited 30 patients each group, B group recruited 20 patients.
Who may be able to join
- A、B group were enrolled standards: ① aged 18-65 years old; ② comply with percutaneous nephrolithotomy lithotripsy indications for surgery; ③ ECT tips ipsilateral normal or mildly impaired renal function.
- Group C patients were enrolled standards: ① aged 18-65 years old; ② normal renal function, not associated with urinary calculi in patients; ③ cancer patients met radical nephrectomy indications for surgery; ④ emergency trauma patients suffering from kidney resection surgical indications.
Who cannot join
- aged <18 years or> 65 years; ② neurological disease or cognitive dysfunction; ③ can not be corrected or uncorrected coagulopathy; ④ associated with diabetes, hypertension and other metabolic diseases; ⑤ accompanied by tuberculosis, hepatitis, HIV and other infectious diseases; ⑥ poor tolerance to anesthesia and surgery, such as: severe cardiopulmonary disease, coagulation disorders, etc.; ⑦ ultrasound, renal imaging examination revealed renal cortex was significantly thinner (renal cortical thickness <1.5cm), structural variation; ⑧ with severe systemic or urinary tract infection; ⑨ ECT tips ipsilateral renal function is severely impaired or solitary kidney.
About this study
This study intends to use in patients with renal tissue and blood samples, screening and identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further study of uric acid stone formation mechanism and the occurrence of clinical preventive uric acid stones provide new clues and new intervention targets.
- Conditions
- Urinary Calculi
- Medical subject headings
- Urinary 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 |
|---|---|---|
| non-urate calculus | Not described | |
| non-calculus | Not described | |
| urate calculus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
micro-RNA
microRNA microarray:the micro-RNA of kidney tissue
Measured: 6 months
Secondary outcomes (5)
Urine
Urine Analyzer:Urine color, transparency, pH, erythrocytes, leukocytes, epithelial cells, casts, protein, specific gravity, and qualitative urine
Measured: 24 hours
24h urine quantitative analysis
Urine Analyzer:Urine, sodium, potassium, calcium, magnesium, ammonium, phosphate, sulfate, uric acid, oxalate, citrate, creatinine
Measured: 96 hours
Blood biochemistry
Blood biochemical analyzer:Sodium, potassium, chloride, calcium, phosphorus, magnesium, bicarbonate, uric acid, creatinine
Measured: 24 hours
Stone analysis
Infrared Spectroscopy:Calcium oxalate monohydrate , carbonated apatite, calcium oxalate dihydrate ,anhydrous uric acid, urine ammonium,magnesium ammonium phosphate
Measured: 3 weeks
hURAT1 transporter protein
WESTERN BLOT、RT-qPCR:hURAT1 transporter protein of kidney tissue
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 posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qian-wei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qian-wei Li, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973088
- Sponsor's protocol ID
- Southwest Hospital,TMMU
- Status last verified
- Sep 2013
- First submitted
- 20 Oct 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Identification of Human Urate Transporter hURAT1 MicroRNA
- ClinicalTrials.gov ID
- NCT01973088
- Acronym / sponsor ID
- Southwest Hospital,TMMU
- Conditions
- Urinary Calculi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qian-wei LiUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (estimated)
- First posted
- 31 Oct 2013 (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.
This study intends to use in patients with renal tissue and blood samples, screening and identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further study of uric acid stone formation mechanism and the occurrence of clinical preventive uric acid stones provide new clues and new intervention targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-urate calculus | – | – |
| non-calculus | – | – |
| urate calculus | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Experiment are divided into uric acid stones group (A), non-uric acid stones group (B), control group (C), A, C recruited 30 patients each group, B group recruited 20 patients.
Key inclusion criteria (2 listed)
- A、B group were enrolled standards: ① aged 18-65 years old; ② comply with percutaneous nephrolithotomy lithotripsy indications for surgery; ③ ECT tips ipsilateral normal or mildly impaired renal function.
- Group C patients were enrolled standards: ① aged 18-65 years old; ② normal renal function, not associated with urinary calculi in patients; ③ cancer patients met radical nephrectomy indications for surgery; ④ emergency trauma patients suffering from kidney resection surgical indications.
Key exclusion criteria (1 listed)
- aged <18 years or> 65 years; ② neurological disease or cognitive dysfunction; ③ can not be corrected or uncorrected coagulopathy; ④ associated with diabetes, hypertension and other metabolic diseases; ⑤ accompanied by tuberculosis, hepatitis, HIV and other infectious diseases; ⑥ poor tolerance to anesthesia and surgery, such as: severe cardiopulmonary disease, coagulation disorders, etc.; ⑦ ultrasound, renal imaging examination revealed renal cortex was significantly thinner (renal cortical thickness <1.5cm), structural variation; ⑧ with severe systemic or urinary tract infection; ⑨ ECT tips ipsilateral renal function is severely impaired or solitary kidney.
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
micro-RNA
Time frame: 6 months
microRNA microarray:the micro-RNA of kidney tissue
5 secondary outcomes
Urine
Time frame: 24 hours
24h urine quantitative analysis
Time frame: 96 hours
Blood biochemistry
Time frame: 24 hours
Stone analysis
Time frame: 3 weeks
hURAT1 transporter protein
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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 Urinary Calculi, run by Qian-wei Li.
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 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 10 Dec 2013. 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?
Results are not available in the source record.
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?
micro-RNA (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 10 Dec 2013.