Actively Recruiting

Phase Not Applicable
Age: 2Years +
All Genders
NCT06851377

Expanding NGS Data with Optical Genome Mapping (OGM)

Led by IRCCS Eugenio Medea · Updated on 2025-02-28

60

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Expanding NGS Data with Optical Genome Mapping (OGM)

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals without a molecular diagnosis after negative Exome Sequencing (ES) or Chromosomal Microarray Analysis (CMA)
  • Individuals with genetic diagnoses explaining only one part of their primary symptoms
  • Individuals carrying one or more genetic variants of uncertain clinical significance
  • Individuals with symptoms similar to well-defined syndromes (e.g., Marfan Syndrome) but negative on routine molecular tests
Not Eligible

You will not qualify if you...

  • Individuals who have not undergone initial diagnostic genetic tests such as Exome Sequencing (ES) or Chromosomal Microarray Analysis (CMA)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cytogenetic Unit of Medical Genetic Laboratory

Bosisio Parini, Lecco, Italy, 23842

Actively Recruiting

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Research Team

M

Maria Clara Bonaglia PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Expanding NGS Data with Optical Genome Mapping (OGM) | DecenTrialz