Ureteropelvic Junction ObstructionNCT01711996
The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients
An observational study of Ureteropelvic Junction Obstruction, run by Yonsei University at 1 site in South Korea.
Trial summary
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteropelvic Junction Obstruction
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Aug 2013
- 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 Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Group 1: 20 patients with UPJO undergo pyeloplasty Group 2: 20 patients with hydronephrosis who does not meet the indication of pyeloplasty Group 3: 20 normal control
Who may be able to join
- <Group 1>
- 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
- needs pyeloplasty due to differential renal function (DRF)<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO <Group 2>
- 1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty <Group 3>
- 1. 0-3 year old children without any abnormality of urinary tract
Who cannot join
- <Group 1>
- patients with contralateral disease affecting DRF
- history of previous urinary tract surgery
- follow up loss before diuretic renogram performed at 6-12 months from operation <Group 2, 3>
- 1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Seoul, 120-752
About this study
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.
- Conditions
- Ureteropelvic Junction Obstruction
- Keywords
- hydronephrosis, biopsy, biomarker
- Medical subject headings
- Multicystic renal dysplasia, bilateral, Hydronephrosis
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 |
|---|---|---|
| UPJO | 0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty | |
| Hydronephrosis | 0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty | |
| Normal | 0-3 year old children without hydronephrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of urinary NGAL and the degree of renal injury
Analysis of correlation between the level of urinary NGAL and the degree of renal injury
Measured: 6 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2012
- Study completionAug 2013 (estimated)
Why it stopped: Difficulty in purchasing reagents and receiving consent from the subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711996
- Sponsor's protocol ID
- 4-2012-0421
- Status last verified
- May 2021
- First submitted
- 17 Oct 2012
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients
- ClinicalTrials.gov ID
- NCT01711996
- Acronym / sponsor ID
- 4-2012-0421
- Conditions
- Ureteropelvic Junction Obstruction
- Keywords
- hydronephrosis, biopsy, biomarker
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty in purchasing reagents and receiving consent from the subject
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2013 (estimated)
- First posted
- 23 Oct 2012 (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.
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UPJO | – | –0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty |
| Hydronephrosis | – | –0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty |
| Normal | – | –0-3 year old children without hydronephrosis |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Group 1: 20 patients with UPJO undergo pyeloplasty Group 2: 20 patients with hydronephrosis who does not meet the indication of pyeloplasty Group 3: 20 normal control
Key inclusion criteria (5 listed)
- <Group 1>
- 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
- needs pyeloplasty due to differential renal function (DRF)<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO <Group 2>
- 1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty <Group 3>
- 1. 0-3 year old children without any abnormality of urinary tract
Key exclusion criteria (5 listed)
- <Group 1>
- patients with contralateral disease affecting DRF
- history of previous urinary tract surgery
- follow up loss before diuretic renogram performed at 6-12 months from operation <Group 2, 3>
- 1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery
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
The level of urinary NGAL and the degree of renal injury
Time frame: 6 month after operation
Analysis of correlation between the level of urinary NGAL and the degree of renal injury
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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.
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 Ureteropelvic Junction Obstruction, run by Yonsei University at 1 site in South Korea.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 May 2021. 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
The level of urinary NGAL and the degree of renal injury (time frame: 6 month after operation). 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 6 May 2021.