(duplicate) Tuberous Sclerosis Complex Registry Study (TOSCA)
Research type
Research Database
Full title
An international disease registry collecting data of manifestations, interventions and outcomes in patients with tuberous sclerosis complex
IRAS ID
234691
Contact name
Eduardo Chicote
Contact email
Clinicaltrials.gov Identifier
REC Number, 12/WA/0159 ; IRAS number, 106630
Duration of Study in the UK
8 years, 6 months, 25 days
Research summary
Tuberous Sclerosis Complex Registry Study (TOSCA)
REC name
Wales REC 5
REC reference
18/WA/0013
Date of REC Opinion
22 Jan 2018
REC opinion
Favourable Opinion
Data collection arrangements
Following collection of informed consent, patients with TSC and, where applicable, their parents will provide a medical history, including prenatal, genotyping family history, current disease features and manifestations, comorbidities, mTOR treatment details and other treatments and surgical procedures. DAta from samples biopsies, scans, neurocognition tests, and other assessments and procedures collected in the course of the patient routine clinical care will be used, but no procedures will be performed for the purpose of the trial. Patients will be followed up in accordance with standard medical practice and at least once every 12 months. The registry information will be updated on the basis of these follow up visits over a period of up to 6.5 years. Data from approximately 1000 patients with TSC throughout Europe will be collected and entered into the database using 21 CRF Part 11 complaint processes. The disease registry data will be stored in a secure database in the offices of Novartis Pharma AG in Switzerland.
Research programme
The TSC community will benefit from the better understanding of their disease and its treatment that will be gained from the data analysis and future research of this disease registry.
Research database title
Tuberous Sclerosis Complex Registry Study (TOSCA)
Establishment organisation
Novartis Pharmaceuticals AG
Establishment organisation address
Novartis Campus
Switzerland
CH4056