Biologics And Clinical Immunology Cohort at Sinai
Recruiting · NCT04784364 · Observational (researchers observe without assigning treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →What this trial is about
The study team plans to establish a bioregistry of patients receiving biologic therapy as part of their standard treatment at the Mount Sinai Therapeutic Infusion Center and affiliated practices. The study team will to apply state-of-the-art approaches to assessing and predicting immunological and clinical responses associated with these standards and prescribed treatments. The approach is twofold. The first component is to establish a robust and flexible biorepository and database that includes demographic, immunologic, exposure and clinical records, and can facilitate research across disciplines, and across other registries affiliated with Mount Sinai. The second component is to address specific key research questions focused on using novel diagnostics to increase the effectiveness of biologic treatment. Most patients will be recruited from the Mount Sinai Therapeutic Infusion Center (TIC), although others receiving infusions elsewhere or at home will be recruited from outpatient Sinai affiliated clinical practices.
Who can take part
Inclusion criteria
- Age 12 years and up.
- Able to provide informed consent.
- Medical care at Mount Sinai.
- Receiving a biologic medication or immune modulator at Mount Sinai, or considered an appropriate negative control or comparison participant by the study team.
Where it is running
1 location listed across 1 US state.
- Mount Sinai - New York, New York, United States