SIROC Study
Research type
Research Study
Full title
Secure Anonymised Information Linkage (SAIL) databank analysis of Infection Related Outcomes in people with schizophrenia taking Clozapine (SIROC) Study
IRAS ID
179877
Contact name
Stephen Jolles
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
SIROC is an observational study with two arms.
Arm 1 is an investigation of the distribution of serum immunoglobulins in people with schizophrenia. The study population consists of two groups of individuals with schizophrenia: those with treatment-resistant schizophrenia (TRS) receiving clozapine therapy (Group A), and those receiving “conventional” (non-clozapine) antipsychotic therapies (Group B). These individuals will be invited to participate in the study whilst attending for regular monitoring visits at NHS community mental health centres across Wales. Pending appropriate permissions, the research team will obtain a blood sample for immunological testing (alongside routine phlebotomy wherever possible) and review their relevant medical records (for instance to document infection and medication history). De-identified data will be passed to the Secure Anonymised Information Linkage (SAIL) Databank for further analysis.
Arm 2 will examine the personal and societal costs associated with infection-susceptibility in adults with schizophrenia (Groups A and B) participating in Arm 1, and compare these relative to individuals with a known diagnosis of immunocompromise/immunodeficiency (Group C) who have provided consent for linkage of details of their immunodeficiency diagnosis and immunological testing to the SAIL Databank. An age- and gender- matched group of healthy individuals without a known diagnosis of schizophrenia or immunocompromise (Group D) will be identified from the SAIL Databank to provide an additional comparator group.
The two arms will be described separately in this protocol but remain one linked study. More detailed information is given in the sections for each arm.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0016
Date of REC Opinion
12 Jan 2023
REC opinion
Favourable Opinion