Actively Recruiting

Phase Not Applicable
Age: 6Months +
MALE
NCT05867979

Search for Structural Variants in Patients With DSD and Inconclusive Molecular Diagnosis

Led by University Hospital, Montpellier · Updated on 2025-09-30

20

Participants Needed

1

Research Sites

105 weeks

Total Duration

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AI-Summary

What this Trial Is About

The goal of this clinical trial is to identify structural variants by Optical Genome Mapping (OGM) in the described participant population. The main questions it aims to answer are: * Identify constitutional structural variants by OGM of DNA extracted from blood leukocytes of patients with DSD for which the molecular diagnosis is inconclusive. * Identify mosaic structural variants (present in a subpopulation of somatic cells only) by OGM of DNA extracted from blood leukocytes of patients with DSD for which the molecular diagnosis is inconclusive. * Compare the diagnostic yields of OGM and of Comparative Genome Hybridization Array (CGH array) methods. * Compare the diagnostic yields of the OGM and of Whole Genome Sequencing (National Sequencing Program), only if performed. Participants will be required to: * a follow-up interview with a physician to review their own and family medical and surgical history, with a focusing on DSD. * An interview to assess their exposure to environmental pollutants during fetal life, using a validated questionnaire. * a blood test with a 5mL tube to perform optical genome mapping analysis.

CONDITIONS

Official Title

Search for Structural Variants in Patients With DSD and Inconclusive Molecular Diagnosis

Who Can Participate

Age: 6Months +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Homogeneous XY male karyotype
  • Patient at least 6 months old
  • Severe to moderate DSD (Prader 1 to 5) with an inconclusive molecular diagnosis after gene panel analysis
Not Eligible

You will not qualify if you...

  • Subject with homogeneous or mosaic XX, or monosomal X karyotype
  • Subject with an aneuploidy
  • Subject with a conclusive molecular diagnosis explaining the observed DSD (causal genotype well characterized)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Montpellier

Montpellier, France, 34000

Actively Recruiting

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Research Team

F

Françoise PARIS, MD PhD

CONTACT

A

Anne BERGOUGNOUX, PharmD 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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