Clinical trial Recruiting at 1 site Observational Ages Any age to 17

Observing kidney issues in children with tuberous sclerosis

Official title: Observational, Retrospective, Multicenter, Nonprofit Study on the Prevalence of Renal Involvement in Pediatric Patients With Tuberous Sclerosis

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06764602 · Data updated 2026-11-12

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 typeObservational
AgesAny age to 17 Years
SexAll
Enrollment80 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations1 site (Bologna)
StatusRecruiting
StartedJuly 1, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedJanuary 8, 2025
Trial IDNCT06764602 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients older than 18 years or those with other phacomatoses will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.