NCT04784364 · Icahn School of Medicine at Mount Sinai
Biologics And Clinical Immunology Cohort at Sinai
(BACICS)
What this study 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.
View original scientific description
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.
Primary outcome measures
Biologics and Clinical Immunology Registry
Time frame: 3 years
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 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations