Clinical trial NCT03025763: Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones
Official title: Craniosynostosis Network
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Craniosynostosis
Keywords: Craniosynostosis
Bone
Birth Defect
Congenital Anomaly
Malformation
Genetics
Genomics
Skull
Human
Mouse
Imaging
Cell Biology
Induced Pluripotent Stem Cells
System Biology
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-01-20
Enrollment: 2145
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with coronal nonsyndromic craniosynostosis (cNSC) and their relatives and controls (including noncraniosynostosis patients having neurosurgery for another surgical indication) will be included in this study. Approximately 4,000 individuals will participate of either gender and all ages, ethnicities, and race. All research subjects will be consented through approved IRB protocols at Icahn School of Medicine at Mount Sinai or respective collaborating institutions which will be governed by their own institutional IRB committees. Only de-identified medical information, CT scans, and samples from collaborating institutions will be shared with Mount Sinai.

Brief summary: Craniosynostosis (CS) is a common malformation occurring in \~4 per 10,000 live births in which the sutures between skull bones close too early, causing long-term problems with brain and skull growth. Infants with CS typically require extensive surgical treatment and may experience many perioperative complications, including hemorrhage and re-synostosis. Even with successful surgery, children can experience developmental and learning disabilities or vision problems. Most often, CS appears as isolated nonsyndromic CS (NSC). Of the several subtypes of CS, unilateral or bilateral fusion of the coronal suture is the second most common form of CS accounting for 20-30% of all NSC cases. The etiology of coronal NSC (cNSC) is not well understood, although the published literature suggests that it is a multifactorial condition. About 5-14% of coronal craniosynostosis patients have a positive family history, with a specific genetic etiology identified in \>25% of cNSC cases, suggesting a strong genetic component in the pathogenesis of this birth defect. The causes for cNSC and its phenotypic heterogeneity remain largely unknown. An international team of investigators will generate large genomic and gene expression datasets on samples from patients with cNSC. State-of-the-art imaging, genetic, and developmental and systems biology approaches will be used to quantitatively model novel pathways and networks involved in the development of cNSC. Novel variant-, gene- and network-level analyses will be performed on the genomic data obtained from cNSC cases, their relatives, and controls to identify novel variants and genetic regions associated with cNCS. Quantitative, analytical, and functional validations of these predictions will provide insights into the etiology and possible therapeutic targets for CS and potentially other bone-related disorders.

Detailed description: The long-term goal of the Program Project, Craniosynostosis Network, is to elucidate normal and abnormal craniofacial biology to ultimately improve the treatment of craniofacial disorders. Craniosynostosis and other skull abnormalities are among the most common human malformations usually requiring surgical and medical intervention. The Network will integrate three projects and two cores. Scientists with diverse expertise including anthropology, morphometry, imaging, birth defects, developmental biology, genetics, genomics, epidemiology, statistics, and systems biology will explore the determinants of the fate of the relevant mesenchymal progenitor cells, abnormalities in osteogenesis that contribute to global skull growth abnormality and premature closure of cranial sutures, especially the coronal suture. High quality genomic data will be obtained from patients with coronal nonsyndromic craniosynostosis (cNSC) and their available parents. Novel genome-wide variant-, gene- and network-level analyses will be performed on these families to identify novel variants and genetic regions associated with coronal craniosynostosis.

This study is a multi-center, open-enrollment, retrospective study, employing both family-based and case-control study designs.

Approximately 4000 cNSC patients, their family members, and controls will be recruited by Icahn School of Medicine at Mount Sinai and the majority will be recruited from the more than 10 collaborating institutions worldwide.

Eligibility criteria: Inclusion Criteria:

* Cases with diagnosis of coronal
* Unaffected relatives of cases
* Unaffected controls including those who may have undergone clinically indicated craniofacial surgery for trauma or conditions other than craniosynostosis or bone disease. These individuals will be recruited at some of the other collaborating institutions, but not at Mount Sinai.

Individuals of any racial or ethnic group with the established or suspected clinical diagnosis of coronal, nonsyndromic craniosynostosis will be included in this study. Unaffected relatives, such as their biological parents and/or sibs, will also be included to contribute medical information and samples as negative controls for our study.

Exclusion Criteria:

* Those who fit the criteria, but who choose not to participate
* Those who do not meet the criteria.
* Other than children, no vulnerable individuals will be recruited, such as intellectual impaired individuals or prisoners.

Primary outcomes:
measure: Phenotype-genotype gene expression correlations
timeFrame: up to 5 years
Secondary outcomes:
measure: Incidence of gene mutations
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Davis
country: United States
facility: The International Craniosynostosis Consortium at University of California at Davis
state: California
city: Hartford
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Iowa City
country: United States
facility: National Birth Defects Prevention Study at University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Albany
country: United States
facility: Birth Defect Registries of New York State
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Hershey
country: United States
facility: Pennsylvania State Milton S. Hershey Medical Center
state: Pennsylvania
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Austin
country: United States
facility: Seton Family of Hospitals
state: Texas
city: Dallas
country: United States
facility: Medical City Children's Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas at Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Talence
country: France
facility: University of Bordeaux
state: Aquitaine
city: Paris
country: France
facility: INSERM/ Hospital Necker-Enfants Malades
state: Cedex 14
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
state: Esplugues De Llobregat
city: Oxford
country: United Kingdom
facility: Oxford University
state: Oxfordshire
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ethylin Wang Jabs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Inga Peter, PhD
role: PRINCIPAL_INVESTIGATOR
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