RECRUITING

VIGOR: Virtual Genome Center for Infant Health

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

This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has great potential to address disparities in genomic medicine among low-income and underrepresented minority (URM) populations and will enhance capacity for providers and health systems to utilize highly specialized genomic techniques in their communities. The goal of this study is to achieve equitable access to state-of-the-art genomic medical care to sick newborns in community centers that predominately care for low-income and racial/ethnic minority populations through the creation of a virtual genome center (VIGOR). VIGOR will provide a venue for physician and family education, genomic expert consultation, reanalysis of unsolved sequencing data, and access to cutting edge therapeutic innovation, thereby facilitating institutionalization of genomic best practices in community settings, and not just highly specialized referral centers.

Official Title

VIGOR: Virtual Genome Center for Infant Health

Quick Facts

Study Start:2022-03-22
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05205356

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:0 Days to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newborns presenting with probable genetic conditions inpatient on the NICU. These may include (but is not limited to) those with unexplained hypotonia, seizures, metabolic disorders, disorders of sex development, interstitial lung disease, immunodeficiency or multiple congenital anomalies.
  2. * Babies must have at least one biologic parent available for consent and participation.
  3. * The criteria for inclusion are 100% phenotype based and do not include any demographic parameters.
  1. * Presence of a likely nongenetic explanation for the phenotype (e.g., perinatal asphyxia explained by uterine rupture or placental pathology;
  2. * Clinical features pathognomonic for a recognizable chromosomal abnormality, such as trisomy 21;
  3. * Associations already known to have low genetic diagnostic yield, including VATER/VACTERL association and OEIS complex;
  4. * Infants who die before enrollment;
  5. * Known family history of genetic disease that is plausibly the cause of the infant's illness; - Those with a prenatal genetic diagnosis.

Contacts and Locations

Study Contact

Timothy Yu, MD, PhD
CONTACT
617-919-7499
timothy.yu@childrens.harvard.edu
Vanessa J Young, MS, BA, RN
CONTACT
617-355-8330
vanessa.young@childrens.harvard.edu

Principal Investigator

Timothy Yu, MD, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

USA Children's and Women's Hospital
Mobile, Alabama, 36604
United States
Holtz Children's Hospital at Jackson Memorial Medical Center
Miami, Florida, 33136
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
UMass Memorial Hospital
Worcester, Massachusetts, 01605
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
The Women's Hospital at Renaissance
Edinburg, Texas, 78539
United States
The Hospitals of Providence
El Paso, Texas, 79938
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Timothy Yu, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

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 Date2022-03-22
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2022-03-22
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Genetics

Additional Relevant MeSH Terms

  • Genetics Disease
  • Genetics/Birth Defects
  • Genetic Predisposition to Disease