Actively Recruiting
Biologics And Clinical Immunology Cohort at Sinai
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-02-17
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are establishing a bioregistry to study patients receiving biologic therapy as part of their standard treatment for immunological diseases, autoimmune diseases, and primary immune deficiency. This observational study aims to collect detailed demographic, immunologic, exposure, and clinical data to better understand how patients respond to biologic treatments. The research also focuses on developing novel diagnostics to improve the effectiveness of these therapies and addresses key questions about how different biologic treatments impact immune responses and clinical outcomes. The study involves creating a flexible biorepository and database that incorporates biological specimens and questionnaire data. Most participants will be recruited from the Mount Sinai Therapeutic Infusion Center, with additional participants receiving infusions elsewhere or at home included from affiliated outpatient practices. The registry is designed to support ongoing and future research questions, including the effects of specific biologics such as anti-IgE, anti-IL-5, anti-TNF, anti-CD20, and IVIG therapies on immunological pathways and clinical outcomes. Participants will be involved in data and specimen collection over a period of up to three years. The study will use various health questionnaires like the Asthma Control Questionnaire and Clinical Disease Activity Index to track clinical status. Researchers will monitor immunological markers and disease activity scores to assess treatment responses. This long-term observation aims to support precision medicine approaches by linking immunophenotype data with clinical outcomes and facilitating multidisciplinary research collaborations.
CONDITIONS
Brief Title
Biologics And Clinical Immunology Cohort at Sinai
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years and up.
- Able to provide informed consent.
- Receiving medical care at Mount Sinai.
- Currently receiving biologic medication or immune modulator at Mount Sinai, or considered an appropriate control participant by the study team.
You will not qualify if you...
- Not able to provide informed consent.
- Not receiving medical care at Mount Sinai.
- Not receiving biologic medication or immune modulator treatments when required for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or during routine clinical visit)
Duration - Up to 3 years
Participants who are receiving biologic or immune modulator treatments as part of their routine care are observed to collect biological specimens, questionnaire data, and clinical records over time to assess immunological and clinical conditions.
Scheduled medical visits for specimen and data collection; visit frequency depends on routine care schedules
Trial Site Locations
Total: 1 location
1
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Sarah Alvi
S
Sonia Parmar
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here