Observing kidney issues in children with tuberous sclerosis
Observational, Retrospective, Multicenter, Nonprofit Study on the Prevalence of Renal Involvement in Pediatric Patients With Tuberous Sclerosis
This study looks at kidney problems, like cysts and tumors, in children with tuberous sclerosis to better understand how common these issues are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06764602 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of renal involvement, specifically angiomyolipomas and renal cysts, in pediatric patients diagnosed with tuberous sclerosis complex (TSC). It is a retrospective, multicenter, nonprofit study that evaluates clinical data from patients under 17 years of age who were diagnosed with TSC between January 1, 2018, and June 30, 2021. The study seeks to fill the gap in literature regarding renal complications in this population, which can lead to severe health issues, including chronic kidney disease and increased risk of renal carcinoma.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 17 years old diagnosed with tuberous sclerosis who have been clinically evaluated in a healthcare setting.
Not a fit: Patients older than 18 years or those with other phacomatoses will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the prevalence of kidney complications in children with tuberous sclerosis, potentially leading to improved monitoring and management strategies.
How similar studies have performed: While there is limited data on renal involvement in pediatric TSC patients, similar studies in adult populations have highlighted significant renal complications, suggesting a need for further investigation in children.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of either sex under the age of 17 years at the time of last observation (06/30/2021); * Patients clinically evaluated in an outpatient or inpatient setting during 01/01/2018- 30/06/2021 with a diagnosis of TSC; * Informed consent signed by parent or legal guardian. Exclusion Criteria: * Patients older than 18 years of age; * Patients with other phacomatoses.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Pasini, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Andrea Pasini, MD
- Email: andrea.pasini@aosp.bo.it
- Phone: 00390512144613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.