SNP-based Prediction of Recurrence Risk in Kidney Stone P... | NCT04937192

Studies
SNP-based Prediction of Recurrence Risk in Kidney Stone Patients

NCT04937192

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Status

Unknown status

Last Update Posted

Oct 25, 2022Actual

Enrollment

1,300Estimated

Phase

Not provided

Conditions

Kidney Stone

Interventions

No intervention

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 10, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 23, 2021Actual

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 23, 2022

Last Update Posted Date

Oct 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guohua Zeng, Vice president, The First Affiliated Hospital of Guangzhou Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Guangzhou Medical UniversityOTHER

Collaborators

Name	Class
Xiangya Hospital of Central South University	OTHER
Wuhan University Renmin Hospital	UNKNOWN
The Second Affiliated Hospital of Kunming Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 goal of this study is to gain new knowledge about genetic risk factors that may affect the kidney stone recurrence. The study seeks to understand if different forms of genes result in an increased risk of kidney stone recurrence.

Detailed Description

In this study, investigators are prospectively testing whether SNP are associated with kidney stone recurrence. Investigators will test the hypothesis that SNP predispose kidney stone patients to recurrence.

Investigators hope to identify predictors for the kidney stone recurrence. This would allow the identification of a subpopulation of kidney stone patients that would benefit most from prevention measures.

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

Retention

Enrollment

1,300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kidney stone former			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Kidney stone former

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone-free survival	Time to first stone recurrence from stone-free	From date of stone-free until the date of first stone recurrence (up to 7 years)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Kidney stone former who the stone was removed completely.
Ability to give informed consent

Exclusion Criteria:

Patient refuses or is unable to give consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Kidney stone former who the stone was removed completely

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guohua Zeng, M.D.	Contact	13802916676		gzgyzgh@vip.sina.com
Wei Zhu, M.D.	Contact	13622754991		doczw1989@126.com

Overall Officials

Name	Affiliation	Role
Guohua Zeng, M.D.	The First Affiliated Hospital of Guangzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Guangzhou Medical University	Recruiting	Guangzhou	Guangdong	510120	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D012008	Recurrence

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided