Recruiting

Diagnostic Study

Sponsor:

Rady Pediatric Genomics & Systems Medicine Institute

Code:

NCT05457140

Conditions

Psychosis

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Genetic: Genomic sequencing and molecular diagnostic results, if any.

Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)

Study Details

Brief summary:

Rady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with psychotic symptoms or schizophrenia. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatment for future patients.

Conditions

Psychosis

Study ID

NCT05457140

Start date

Oct 10, 2022

Status verified date

Nov, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individual in whom one of the following criteria is met:

1. Child/adolescent admitted to the Rady Children's CAPS with symptoms of first break psychosis

OR
2. Biological parents of child/adolescent enrolled in this study for the purposes of reflex testing. Family members are eligible for participation in this study if they are presumed genetically related to a patient participant.

Exclusion Criteria:

Child/Adolescent patients who do not meet any of the inclusion criteria, or those who:

1. Already received any prior whole genome sequencing or exome sequencing.
2. Unable to approach the family or patient for enrollment.
3. Unable to obtain informed consent.
4. Family members are ineligible for participation in this study if:

1. They are known to not be genetically related to the child/adolescent patient participant
2. They are a member of a protected research population

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Enrollees - WGS

These participants will be subject to whole genome sequencing and Phage ImmunoPrecipiation sequencing (PhIP-Seq) to identify genetic changes and novel antibodies associated with psychosis.

Interventions

Genetic: Genomic sequencing and molecular diagnostic results, if any.

Genomic sequencing results may be used for diagnosis and treatment of participants.

Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)

Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies.

Primary outcome measure

  • Diagnostic rate of brain reactive autoantibodies [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Aaron Besterman, MD

858-576-1700abesterman@health.ucsd.edu

Corrine Blucher, BS

858-576-1700cblucher@rchsd.org

Locations

Rady Children's Hospital San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Aaron Besterman, MD, MD

858-576-1700abesterman@health.ucsd.edu

Corrine Blucher, BS

8585761700cblucher@rchsd.org

More Information

Sponsor

Rady Pediatric Genomics & Systems Medicine Institute

Last update posted

Nov 14, 2024

Last verified

Nov, 2024

Keywords

  • Genomic
  • Pediatric
  • Rady Children's Hospital

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rady Pediatric Genomics & Systems Medicine Institute on 2024-11-14.