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NCT Number: NCT06880094

Study of Congenital Orofacial Clefts by Implementing Optical Genome Mapping

Orofacial clefts, the most common congenital craniofacial malformations, have a complex etiology involving an interaction between genetic and environmental factors.

Chromosomal abnormalities, including structural variations, represent a major cause of human pathology. Recently, technological developments and the introduction of next-generation sequencing (NGS) technologies have revolutionized the field of medical genetics.

Optical genome mapping (OGM) is an innovative, high-resolution "long read" technique that enables the identification of all classes of chromosomal variation, consisting in the direct visualization of long, labeled DNA molecules throughout the genome. This technology is gradually becoming an essential tool for studying onco-hematology and constitutional genetic pathologies The purpose of this study is to search for structural chromosomal variants (SV) or copy number variants (CNV) not identifiable either by cytogenetic methods nor by "short read" NGS "short read, in individuals with oral-facial clefts with no genetic diagnosis.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Benedicte Demeer, MD

CONTACT

[email protected]

33+322087581

Emilien Colin, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with syndromic, complex or familial oral-facial clefts
  • With no established genetic diagnosis
  • Followed up at the Amiens-Picardie University Hospital

Exclusion criteria

  • genetic diagnosis of oral-facial cleft
  • No health insurance affiliation
  • Patient under guardianship or curatorship, under safeguard of justice or deprived under public law
  • Pregnant, parturient or breast-feeding woman

Treatment and study plan

blood withdrawal

Genetic

blood withdrawal for genetic testing

Primary outcomes

  1. Identification of a structural chromosomal variant

    Time frame: 2 years

    Identification of a structural chromosomal variant involved in the genesis of orofacial clefts by studying the genetic characteristics of individuals with orofacial clefts.

Study contacts

Contact information is provided by the study sponsor or research team.

Bénédicte DEMEER, MD

CONTACT

[email protected]

33+322087581

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: CARTOFENTE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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