RECRUITING

Biologics and Clinical Immunology Cohort At Sinai

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Biologics and Clinical Immunology Cohort At Sinai

Quick Facts

Study Start:2021-03-03
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04784364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 12 years and up.
  2. * Able to provide informed consent.
  3. * Medical care at Mount Sinai.
  4. * Receiving a biologic medication or immune modulator at Mount Sinai, or considered an appropriate negative control or comparison participant by the study team.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sarah Alvi
CONTACT
212-659-9416
Sarah.Alvi@mssm.edu
Sonia Parmar
CONTACT
973-944-8221
sonia.parmar@mssm.edu

Principal Investigator

Rachel Miller
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine

Study Locations (Sites)

Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Rachel Miller, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-03
Study Completion Date2028-11

Study Record Updates

Study Start Date2021-03-03
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • Asthma
  • Immune Deficiency
  • Autoimmunity

Additional Relevant MeSH Terms

  • Immunological Disease
  • Autoimmune Diseases
  • Primary Immune Deficiency