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Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones
NCT03025763 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Skin Biopsy
- OTHER Craniosynostosis Network Environmental Survey
- OTHER 2D/3D Photography
- PROCEDURE Buccal Swab Cell Sampling
- PROCEDURE Blood sampling
Study Locations (20)
New York
- Birth Defect Registries of New York State — Albany
- New York University — New York
- Icahn School of Medicine at Mount Sinai — New York
Texas
- Seton Family of Hospitals — Austin
- Medical City Children's Hospital — Dallas
- University of Texas at Southwestern — Dallas
Pennsylvania
- Pennsylvania State Milton S. Hershey Medical Center — Hershey
- Pennsylvania State University — University Park
California
- The International Craniosynostosis Consortium at University of California at Davis — Davis
Connecticut
- Yale University — Hartford
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Iowa
- National Birth Defects Prevention Study at University of Iowa — Iowa City
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,145 participants |
| Start Date | 2015-01-13 |
| Est. Completion | 2028-01-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03025763
The ClinicalTrials.gov registry entry for NCT03025763 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Craniosynostosis appearing as the primary indexed condition, and to 5 interventions — of which Skin Biopsy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03025763 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Texas, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03025763 about?
NCT03025763 is a clinical study titled "Network Of Clinical Research Studies On Craniosynostosis, Skull Malformations With Premature Fusion Of Skull Bones". 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 perioperativ...
What is the current status of trial NCT03025763?
This trial is currently active not recruiting. The enrollment target is 2,145 participants. The study started on 2015-01-13. Estimated completion is 2028-01-31.
What conditions does trial NCT03025763 study?
This clinical trial studies the following conditions: Craniosynostosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03025763?
The interventions under investigation include: Skin Biopsy (PROCEDURE), Craniosynostosis Network Environmental Survey (OTHER), 2D/3D Photography (OTHER), Buccal Swab Cell Sampling (PROCEDURE), Blood sampling (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03025763?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03025763 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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