Biorepository for patients receiving biologic therapy at Mount Sinai
Biologics And Clinical Immunology Cohort at Sinai
Icahn School of Medicine at Mount Sinai · NCT04784364
This study is collecting health information from patients receiving biologic therapy at Mount Sinai to help improve treatments for various immune-related diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04784364 on ClinicalTrials.gov |
What this trial studies
This study aims to create a biorepository and database for patients undergoing biologic therapy at the Mount Sinai Therapeutic Infusion Center. It will collect demographic, immunologic, exposure, and clinical records to facilitate research across various immunological diseases. The study will also focus on using novel diagnostics to enhance the effectiveness of biologic treatments over time. Most participants will be recruited from the infusion center, with additional recruitment from outpatient practices.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older who are receiving biologic medications or immune modulators at Mount Sinai.
Not a fit: Patients not receiving biologic therapy or those who do not meet the age and consent criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the effectiveness of biologic therapies for patients with immunological diseases.
How similar studies have performed: Other studies have shown success in utilizing biorepositories to enhance treatment outcomes in immunological diseases, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Rachel Miller — Icahn School of Medicine
- Study coordinator: Sarah Alvi
- Email: Sarah.Alvi@mssm.edu
- Phone: 212-659-9416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immunological Disease, Autoimmune Diseases, Primary Immune Deficiency, Asthma, Immune Deficiency, Autoimmunity