An interventional study of Genetic: Genomic sequencing and molecular diagnostic results, if any. and Phage display ImmunoPrecipiation Sequencing (PhIP-Seq) in Catatonia, sponsored by Rady Pediatric Genomics & Systems Medicine Institute. Not yet recruiting. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Rady Pediatric Genomics & Systems Medicine Institute · Not applicable, Interventional, and Diagnostic
Rady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 40 children and adolescents who are admitted to Rady Children's Hospital San Diego with a catatonia diagnosis. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve the ability to identify the cause of catatonia and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of catatonia that may inform new treatment for future patients.
Catatonia is a complex condition that affects children's behavior, movement, and emotions. It can be caused by various underlying health issues, such as genetic disorders or problems with the immune system. Identifying these underlying causes is crucial for providing the best care and treatment to affected children. In this study, the investigators aim to compare the effectiveness of traditional medical tests with a more advanced approach that includes genetic testing and immune system screening in finding the underlying causes of catatonia in children. The investigators will compare two groups of children with catatonia. One group will be identified from hospital records and will have undergone standard medical tests to find the cause of their catatonia. The other group will be a new set of patients who will receive both standard medical tests and additional advanced testing, including genome sequencing (a technique that reads the entire genetic code) and screening for antibodies that attack the brain. The investigators will use a statistical method called propensity score matching to make sure that the two groups are as similar as possible in terms of age, sex, and other relevant factors. This will help the investigators to fairly compare the effectiveness of the two approaches in identifying the underlying causes of catatonia. The investigators expect that combining standard medical tests with genome sequencing and autoantibody screening will be more effective in finding the underlying causes of catatonia in children compared to using standard medical tests alone. This could lead to more accurate diagnoses and more targeted treatments for children with catatonia, helping them to recover more quickly and improving their quality of life. If this study shows that the advanced testing approach is more effective in finding the underlying causes of catatonia, this could change the way doctors approach the diagnosis and treatment of this complex condition. In turn, this could lead to more accurate diagnoses, tailored treatments, and improved outcomes for children with catatonia and their families.
22 studies on the registry are indexed under Catatonia; 10 are open to participants now.
This study's planned enrollment of 120 is above the median of 63 across 14 interventional studies indexed under Catatonia.
Browse Catatonia studies →Rady Pediatric Genomics & Systems Medicine Institute is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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Individual in whom one of the following criteria is met:
Child/adolescent Ages 0-17 (2) with a diagnosis of catatonia.
OR
Exclusion Criteria:
Child/adolescents patients who do not meet any of the inclusion criteria, or those who:
Family members are ineligible for participation in this study if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
These participants will be subject to whole genome sequencing and Phage ImmunoPrecipiation sequencing (PhIP-Seq) to identify genetic changes and novel antibodies associated with catatonia.
Genetic: Genetic: Genomic sequencing and molecular diagnostic results, if any. · Diagnostic Test: Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)
Genomic sequencing results may be used for diagnosis and treatment of participants.
Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies.
Diagnostic rate of whole genome sequencing
Evaluate the impact of whole genome sequencing on diagnostic yield in pediatric catatonia, compared to standard medical workup.
Time frame: 2 years
Diagnostic rate of brain reactive autoantibodies
Diagnostic rate of brain reactive autoantibodies via genomic and whole human proteome programmable phage display immunoprecipitation sequencing (PhIP-Seq)
Time frame: 2 years
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Rady Pediatric Genomics & Systems Medicine Institute