NCT03003312

Brief Summary

Objective:The aim of this study is to investigate the prevalence and associated factors of pediatric urolithiasis in Kashgar area in China. Methods: The investigators carry out a cross-sectional survey among children aged 0 to14 years across Kashgar area in China. The participants are selected by a two-stage and clustered random sampling method. Participants are asked to undergo urinary tract ultrasonographic examinations, provided blood and urine samples to analyze. Their parents or guardians are asked to fill out the questionnaires. Children those who are found with any abnormalities of their urinary system by ulrtasonography will undergo a low-dose computed tomography (CT) to confirm the abnormalities. The end point of this study is to calculate the prevalence rate, distribution and associated factors of pediatric urolithiasis in Kashi area.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,751

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 28, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

October 27, 2016

Last Update Submit

December 21, 2016

Conditions

Urolithiasis

Keywords

UrolithiasisUyghurPrevalenceAssociated factorsChildren

Outcome Measures

Primary Outcomes (1)

  • Prevalence of urolithasis among children in Kashgar area in Xinjiang, China.

    We are conducting a cross-sectional and ultrosound based survey among children aged 0 to 14 years across Kashgar area in China to evaluate the prevalence and associated factors of urolithiasis.This survey has been started in July 2016.

    From July 2016 to June 2017

Secondary Outcomes (4)

  • The weight of children aged 0 to 14 years in Kashgar area in Xinjiang, China.

    From July 2016 to June 2017

  • The development status of children aged 0 to 14 years in Kashgar area in Xinjiang, China.

    From July 2016 to June 2017

  • The development status of children aged 0 to 14 years in Kashgar area.

    From July 2016 to June 2017

  • Associated factors of urolithasis among children in Kashgar area in Xinjiang, China.

    From July 2016 to June 2017

Other Outcomes (1)

  • The nutrition status between children with urolithiassis and healthy kids.

    From July 2016 to June 2017

Eligibility Criteria

Age1 Day - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 0 to 14 years live in Kashgar area in China.

You may qualify if:

  • Children aged 0 to 14 years and live in Kashgar area in China.

You may not qualify if:

  • Children aged 15 to 17 years live in Kashgar area in China.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

The First People's Hospital of Kashgar Area

Kashgar, Xinjiang, China

RECRUITING

Related Publications (4)

  • Penido MG, Tavares Mde S. Pediatric primary urolithiasis: Symptoms, medical management and prevention strategies. World J Nephrol. 2015 Sep 6;4(4):444-54. doi: 10.5527/wjn.v4.i4.444.

    PMID: 26380196RESULT

  • Clayton DB, Pope JC. The increasing pediatric stone disease problem. Ther Adv Urol. 2011 Feb;3(1):3-12. doi: 10.1177/1756287211400491.

    PMID: 21789094RESULT

  • Wang HH, Wiener JS, Lipkin ME, Scales CD Jr, Ross SS, Routh JC. Estimating the nationwide, hospital based economic impact of pediatric urolithiasis. J Urol. 2015 May;193(5 Suppl):1855-9. doi: 10.1016/j.juro.2014.09.116. Epub 2014 Oct 8.

    PMID: 25305358RESULT

  • Dwyer ME, Krambeck AE, Bergstralh EJ, Milliner DS, Lieske JC, Rule AD. Temporal trends in incidence of kidney stones among children: a 25-year population based study. J Urol. 2012 Jul;188(1):247-52. doi: 10.1016/j.juro.2012.03.021. Epub 2012 May 15.

    PMID: 22595060RESULT

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample of each child will be preserved in a -80℃refrigerator for further analysis of etiology of urolithiasis which include genetics.

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Guohua Zeng, PH.D and M.D

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Guohua Zeng, PH.D and M.D

CONTACT

+86 13802916676gzgyzgh@vip.sina.com

Zanlin Mai, M.D.

CONTACT

+86 34296202maizanlin1001@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice-president

Study Record Dates

First Submitted

October 27, 2016

First Posted

December 28, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 28, 2016

Record last verified: 2016-11

Locations

CN(2)