Quality of Life for Pediatric Urolithiasis | NCT06092203

Studies
Quality of Life for Pediatric Urolithiasis

NCT06092203

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Oct 23, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pediatric ALL

Interventions

Not provided

Countries

Egypt

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 2023

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

Feb 1, 2023Actual

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Oct 10, 2023

First Submission Date that Met QC Criteria

Oct 15, 2023

First Posted Date

Oct 23, 2023Actual

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 15, 2023

Last Update Posted Date

Oct 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease.

Detailed Description

This study will assess the quality of life (QoL) in pediatric patients with urinary stone disease using the pediatric quality of life (PedsQol) questionnaire in comparison to normal healthy age/sex matched population.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Pediatric patients who underwent treatment for utrollithiasis.
Control		Cross-matched group of healthy children.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The PedsQL questionnaire	comparison of overall PedsQL score between pediatric urolithiasis patients and normal healthy age/sex matched population.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who had urinary stones

Exclusion Criteria:

Patients presenting with obstructive uropathy or urosepsis.
Recent (less than 4 weeks) surgical intervention for urinary stone disease.
Indwelling urinary catheters or stents (urethral catheter, ureteral stents or nephrostomy tube).
Associated mental illness or cognitive dysfunction.
Associated chronic medical illness that may compromise QoL.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All pediatric patients with urolithiasis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed R EL-Nahas, MD	Contact	+201221136899		ar_el_nahas@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed R EL-Nahas, MD	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center	Recruiting	Al Mansurah		35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D052878	Urolithiasis

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided