NYCKidSeq: Incorporating Genomics Into Clinical Care of Diverse NYC Children

Summary

The NYCKidSeq program will significantly advance the implementation of genomic medicine, particularly for children, young adults and their families in Harlem and the Bronx. The study will assess the clinical utility of genomic medicine in three broad areas of pediatric disorders, while engaging a range of providers and community advisors to overcome the well-documented barriers to inclusion of underserved and underrepresented populations in genomic research. The study will also include testing, analyzing, and implementing a novel communication tool, Genomic Understanding, Information and Awareness (GUÍA), to facilitate the return of genomic test results. The use of GUÍA will enhance the understanding of these genomic testing results by families, patients, and care providers at all levels of expertise, in two health systems. Healthcare system leadership will be engaged to provide insights into their readiness for genomic implementation. Overall, the NYCKidSeq program will inform the genomics and clinical communities about how to implement genomic medicine in a diverse population in a clinically useful, technologically savvy, culturally sensitive, and ethically sound manner.

Conditions

• Genetic Diseases, Inborn
• Genetic Predisposition to Disease

Interventions

BEHAVIORAL

Standard of Care

Participants will receive traditional genetic counseling (GC) for the Baseline and Return of Results (ROR1) visits.

BEHAVIORAL

GUÍA

GUÍA for the ROR1 visit.

Sponsors & Collaborators

• Albert Einstein College of Medicine

  collaborator OTHER

• New York Genome Center

  collaborator OTHER

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Eimear Kenny, PhD · Icahn School of Medicine at Mount Sinai

• Melissa Wasserstein, MD · Albert Einstein College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-30

Primary Completion

2022-04-28

Completion

2022-04-28

Countries

• United States

Study Locations