Etiological Diagnosis of Urinary Stone in Chinese Children | NCT02949323

Studies
Etiological Diagnosis of Urinary Stone in Chinese Children

NCT02949323

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Oct 31, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Urinary Stone

Interventions

urinary stone

Countries

China

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Oct 26, 2016

First Submission Date that Met QC Criteria

Oct 28, 2016

First Posted Date

Oct 31, 2016Estimated

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

Oct 28, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongquan Geng, Director, Department of Pediatric Urology, Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children with urinary stones		children with urinary stones	Other: urinary stone
children without urinary stones		children without urinary stones

Interventions

Name	Type	Description	Arm Group Labels	Other Names
urinary stone	Other	patients of group one have urinary stones	children with urinary stones

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary oxalate;		urine collected in 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Urinary citrate;		urine collected in 24 hours
Urinary calcium		urine collected in 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with urinary stones

Exclusion Criteria:

Anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature >38°C and/or positive urine culture), solitary kidney, and renal insufficiency

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

Children with urinary stones

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongquan Geng, M.D	Contact	+86-13801973493		ghongquan@hotmail.com
Lei He, M.D	Contact	+86-13918845298		lyghelei@163.com

Overall Officials

Name	Affiliation	Role
Hongquan Geng, M.D	Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Study Chair
Lei He, M.D	Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014545	Urinary Calculi
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D052878	Urolithiasis
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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