The Correlation Between Renal Injury and Biomarkers in Pe... | NCT01711996

Studies
The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients

NCT01711996

Sponsor

Yonsei University

Status

Withdrawn

Last Update Posted

May 6, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Ureteropelvic Junction Obstruction

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in purchasing reagents and receiving consent from the subject

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2013Estimated

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 22, 2012

First Posted Date

Oct 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2021

Last Update Posted Date

May 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 month after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine		Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
C537373	Multicystic renal dysplasia, bilateral
D006869	Hydronephrosis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided