Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones
Public ClinicalTrials.gov record NCT03025763. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Craniosynostosis Network
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03025763
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,145 participants
Conditions and interventions
Conditions
Interventions
- Craniosynostosis Network Environmental Survey Other
- 2D/3D Photography Other
- Buccal Swab Cell Sampling Procedure
- Blood sampling Procedure
- Skin Biopsy Procedure
- Tissues from a Clinically Indicated Procedure Procedure
- Pre-operative CT Scan Image Files. Procedure
Other · Procedure
Eligibility (public fields only)
- Age range
- Up to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 12, 2015
- Primary completion
- Jan 30, 2028
- Completion
- Jan 30, 2028
- Last update posted
- Jan 1, 2025
2015 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The International Craniosynostosis Consortium at University of California at Davis | Davis | California | 95616 | — |
| Yale University | Hartford | Connecticut | 06520 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| National Birth Defects Prevention Study at University of Iowa | Iowa City | Iowa | 52242 | — |
| Johns Hopkins University | Baltimore | Maryland | 21218 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Birth Defect Registries of New York State | Albany | New York | 12237 | — |
| New York University | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Pennsylvania State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Pennsylvania State University | University Park | Pennsylvania | 16802 | — |
| Seton Family of Hospitals | Austin | Texas | 78723 | — |
| Medical City Children's Hospital | Dallas | Texas | 75230 | — |
| University of Texas at Southwestern | Dallas | Texas | 75390 | — |
| University of Utah | Salt Lake City | Utah | 84158 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03025763, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 1, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03025763 live on ClinicalTrials.gov.