RecruitingNot ApplicableNCT06851377

Expanding NGS Data with Optical Genome Mapping (OGM)

Expanding NGS Data with Optical Genome Mapping (OGM): More Comprehensive Variant Detection in Children with Unexplained Rare Genetic Disorders


Sponsor

IRCCS Eugenio Medea

Enrollment

60 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Over 50% of pediatric neurological and neurodevelopmental disorders lack a molecular diagnosis after standard DNA sequencing and molecular karyotyping. This is due to technical limitations, incomplete variant interpretation, and inadequate genotype-phenotype correlations. New sequencing technologies are crucial for clinical decision-making, offering complete profiles of variants in a patient's DNA to personalize treatment. Optical Genome Mapping (OGM) can detect nearly all structural variants in one experiment. This project aims to use OGM alongside NGS to improve diagnostic yield in 60 children with severe disorders who tested negative for NGS/CMA.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Optical Genome Mapping (OGM) and Whole Genome Sequencing (WGS) and Trascriptome analysis for people with neurodevelopmental disorder (diagnosis). The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICOptical Genome Mapping (OGM) and Whole Genome Sequencing (WGS)

After identifying causal SVs via OGM, WGS will determine rearrangement breakpoints and examine nearby genes within 100 kb that may have altered expression due to positional effects.

OTHERTrascriptome analysis

Following genomic characterization results, transcriptome analysis will be performed on patient-derived lymphoblastoid B-cell lines or fibroblasts to investigate the molecular implications of candidate SVs found in the OGM analysis and identify potential transcriptome abnormalities, such as splicing variants, in patients with atypical clinical features.


Locations(1)

Cytogenetic Unit of Medical Genetic Laboratory

Bosisio Parini, Lecco, Italy

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NCT06851377


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