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RECRUITING
NCT06776341

Natural History Study of GEMIN-5 Related Neurodevelopmental Disorder

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

This study will include a comprehensive retrospective chart review and a longitudinal prospective observational natural history study to characterize the phenotypic spectrum of GEMIN5-Related Neurodevelopmental Disorder. We aim to define the trajectory of this ultra-rare disease, core clinical features, characteristics at disease onset and diagnosis, neurological symptomatology, and neuroimaging findings over time. In this study, biological specimens (serum) will also be collected in a biorepository for translational research purposes.

Official title: Retrospective and Longitudinal Prospective Natural History Study of GEMIN5-Related Neurodevelopmental Disorder

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-07-07

Completion Date

2050-12

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

OTHER

GEMIN5-Related Neurodevelopmental Disorder

This is an observational study. The investigators will collect data from participants' medical records regarding neurodevelopmental outcomes (eg. cognitive, speech and language, motor skills, developmental skills, vision, hearing), Time to event (Acquistion and loss of developmental milestones), and, if available, data regarding MRIs (presence of cerebellar atrophy), survival, visiion, hearing, and biomarkers of disease.

Locations (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States