Actively Recruiting

All Genders
NCT06776341

Natural History Study of GEMIN-5 Related Neurodevelopmental Disorder

Led by University of Pittsburgh · Updated on 2025-08-12

500

Participants Needed

1

Research Sites

1325 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Natural History Study of GEMIN-5 Related Neurodevelopmental Disorder

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with molecularly confirmed GEMIN5 biallelic mutations, ages 0 years and above
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

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Research Team

K

Kate Kielty, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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