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Biologics And Clinical Immunology Cohort at Sinai

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Most subjects will be recruited from the Mount Sinai Therapeutic Infusion Center (TIC), although others receiving infusions elsewhere or at home will be recruited from outpatient affiliated clinical practices during scheduled medical visits."
  • "Specific Aims: 1\. (Overarching) Build a repository of biological specimens, questionnaire data, and apply state-of-the-art assessment tools to assess the current immunological and clinical condition, and changes over time."
  • "The Mount Sinai Therapeutic Infusion Center is an ideal location where investigators have the potential to fill in many of these research gaps."
  • "Primary and Secondary Study Endpoints The initial scientific hypotheses focus on these endpoints: Aim 1 An expanded repository of biological specimens and questionnaire data."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects samples and health records to learn how people respond to biologic medicines, which act on the immune system. It aims to find tests that may help make these treatments work better. It is for Mount Sinai patients ages 12 and older who receive these medicines, and some people chosen for comparison.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 12 years old or older.
  • You can give informed consent, meaning you understand the study and agree to join.
  • You get medical care at Mount Sinai.
  • You receive a biologic medicine or immune modulator—a medicine that acts on the immune system—at Mount Sinai, or the study team chooses you as a comparison participant.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official 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.

    Study sites (1)

    NY