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RECRUITING
NCT05867979
NA

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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.

Official title: Search for Structural Variants in Patients With Disorders of Sex Development (DSD) and Inconclusive Molecular Diagnosis GENEXPLOR-DSD

Key Details

Gender

MALE

Age Range

6 Months - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-02-05

Completion Date

2026-02-15

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Identify structural variants by Optical Genome Mapping of DNA extracted from blood leukocytes

The one arm of the study will have a venous blood draw as part of the research. 1 EDTA tube of 5mL will be collected.

Locations (1)

University Hospital Montpellier

Montpellier, France