Biologics And Clinical Immunology Cohort at Sinai

NCT04784364 | Recruiting

• 1 other identifier: HSM 20-01252
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunological Disease; Autoimmune Diseases; Primary Immune Deficiency

Keywords

Asthma; Immune Deficiency; Autoimmunity

Outcome Measures

Primary Outcomes (1)

• Biologics and Clinical Immunology Registry

  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.

  3 years

Secondary Outcomes (5)

• Asthma Control Questionnaire (ACQ)

  Up to 3 years

• Multidimensional Health Assessment Questionnaire (MDHAQ)

  Up to 3 years

• Clinical Disease Activity Index CDAI) - need information

  Up to 3 years

• Birmingham Vasculitis Activity Score (BVA)

  Up to 3 years

• Bath Ankylosing Spondylitis Disease Activity

  Up to 3 years

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing treatment at Mount Sinai Therapeutic Infusion Center will be one major source of participants. Active recruitment will focus on patients new to the Infusion Center. These patients and potential subjects will be densified 1-2 weeks in advance following review of the electronic medical record's schedule by a research study coordinator or other investigator. The primary or referring clinical team, or the current Infusion Center medical team, will let the patient know that a study is available, and if the patient is agreeable, that the research team will contact them.

You may qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma blood, Peripheral blood mononuclear cells (PBMC), Salivary DNA self-collection, Buccal swabs, Tape strips on skin, Nasopharyngeal swab for nasal epithelial cell, Urine

MeSH Terms

Conditions

Immune System Diseases; Autoimmune Diseases; Primary Immunodeficiency Diseases; Asthma; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• Rachel Miller

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Alvi

CONTACT

212-659-9416; Sarah.Alvi@mssm.edu

Sonia Parmar

CONTACT

973-944-8221; sonia.parmar@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Clinical Immunology

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 3, 2021
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to rachel.miller2@mssn.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)