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NCT02887781 Clinical Trial

Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

Tuberous Sclerosis Complex Clinical Trial

— TSAR  

Official title:
Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02887781
Other study ID # TSAR (RB 14.055)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 13, 2015
Est. completion date December 31, 2024

Study information
Verified date January 2024
Source University Hospital, Brest
Contact Yannick LE MEUR, MD PhD
Email yannick.lemeur@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility Inclusion criteria of study participants - Patient presenting with an isolated angiomyolipoma or - Patient presenting with tuberous sclerosis complex combined with an angiomyolipoma or - Patient presenting with tuberous sclerosis complex - Patient not objecting to the study Exclusion criteria of study participants ¦Patient objecting to the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Brest Brest
France CHU Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evolution of the renal function estimated by the MDRD GFR 18 months after inclusion
See also
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Active, not recruiting NCT02962414 - Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment Phase 3
Active, not recruiting NCT05495425 - Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC Phase 3
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Completed NCT01929642 - Rapalogues for Autism Phenotype in TSC: A Feasibility Study Phase 2