Actively Recruiting
Observational, Retrospective, Multicenter Study on Kidney Involvement in Children With Tuberous Sclerosis
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-08
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the prevalence of kidney problems in children with tuberous sclerosis complex (TSC), a genetic disorder caused by mutations in specific genes. TSC often affects the kidneys, leading to growths called angiomyolipomas, cysts, and increased risks of kidney cancer or kidney disease. Kidney issues in TSC can be silent but may cause serious complications like bleeding, anemia, high blood pressure, and kidney failure, making them a leading cause of death in children with TSC after neurological problems. The study is observational and retrospective, gathering data from multiple centers to understand how often kidney involvement occurs in pediatric TSC patients. It focuses on identifying angiomyolipomas and cysts and examining how genetic changes relate to these kidney findings. The study also looks at kidney function and blood pressure outcomes and monitors changes in angiomyolipoma size in children treated with Everolimus for neurological symptoms. Participants undergo clinical evaluations and medical record reviews from outpatient or inpatient visits between 2018 and mid-2021. Researchers measure the stage of angiomyolipomas at the start and assess kidney health through blood pressure and function tests. The study spans from July 2021 to the end of 2025, with a focus on pediatric patients up to 17 years old who have TSC. Informed consent from parents or guardians is required for participation.
CONDITIONS
Brief Title
Observational, Retrospective, Multicenter, Nonprofit Study on the Prevalence of Renal Involvement in Pediatric Patients With Tuberous Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any sex under 17 years old at last observation date (06/30/2021)
- Diagnosed with tuberous sclerosis complex
- Clinically evaluated as outpatient or inpatient between 01/01/2018 and 06/30/2021
- Informed consent signed by parent or legal guardian
You will not qualify if you...
- Patients older than 18 years
- Patients diagnosed with other phacomatoses (similar genetic conditions)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Retrospective data from 01/01/2018 to 06/30/2021
Participants undergo evaluations to assess the presence of renal involvement associated with tuberous sclerosis, including imaging and clinical assessments.
1 to 2 visits depending on clinical evaluation (inpatient or outpatient)
Duration - Up to the last observation date (06/30/2021)
Participants are observed for renal outcomes such as renal function and blood pressure changes over time.
Visits as per routine clinical follow-up, not specified in the study
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
A
Andrea Pasini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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