NCT04784364 Biologics And Clinical Immunology Cohort at Sinai
| NCT ID | NCT04784364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Immunological Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-03-03 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2021-03-03 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Rachel Miller
PRINCIPAL INVESTIGATOR
Icahn School of Medicine
Frequently Asked Questions
Who can join the NCT04784364 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Immunological Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04784364 currently recruiting?
Yes, NCT04784364 is actively recruiting participants. Contact the research team at Sarah.Alvi@mssm.edu for enrollment information.
Where is the NCT04784364 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04784364 clinical trial?
NCT04784364 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Rachel Miller at Icahn School of Medicine. The trial plans to enroll 800 participants.