Pediatric ALLElattarNCT06092203
Quality of Life for Pediatric Urolithiasis
An observational study of Pediatric ALL, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Oct 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All pediatric patients with urolithiasis.
Who may be able to join
- Patients who had urinary stones
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, 35516
Ahmed R EL-Nahas, MD, 00201221136899, ar_el_nahas@yahoo.com
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About this study
Official title: Assessment of Health-Related Quality of Life for Pediatric Patients With Urinary Stone Disease.
The aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease.
Read the 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.
- Conditions
- Pediatric ALL
- Keywords
- Urolithiasis, Quality of life, PCNL, SWL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Pediatric patients who underwent treatment for utrollithiasis. | |
| Control | Cross-matched group of healthy children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PedsQL questionnaire
comparison of overall PedsQL score between pediatric urolithiasis patients and normal healthy age/sex matched population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed R. EL-Nahas, Mansoura University
- Investigators
- Ahmed R EL-Nahas, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092203
- Sponsor's protocol ID
- 2278
- Acronym
- Elattar
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health-Related Quality of Life for Pediatric Patients With Urinary Stone Disease.
- ClinicalTrials.gov ID
- NCT06092203
- Acronym / sponsor ID
- Elattar / 2278
- Conditions
- Pediatric ALL
- Keywords
- Urolithiasis, Quality of life, PCNL, SWL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Pediatric patients who underwent treatment for utrollithiasis. |
| Control | – | –Cross-matched group of healthy children. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients with urolithiasis.
Key inclusion criteria (1 listed)
- Patients who had urinary stones
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The PedsQL questionnaire
Time frame: 12 months
comparison of overall PedsQL score between pediatric urolithiasis patients and normal healthy age/sex matched population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed R EL-Nahas, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed R EL-Nahas, MD (+201221136899, ar_el_nahas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PedsQL questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.