Who is eligible for clinical trial NCT03458962?

Participants must meet protocol criteria for Genetic Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT03458962 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-20

Diagnostic Odyssey: Whole Genome Sequencing (WGS) (NCT03458962)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

🩺 Plain-English Summary (8th-Grade Level)

The goal of this collaborative research is to study human genomes in children with suspected congenital disease, multiple-congenital anomalies and/or multi-organ disease of unknown etiology by understanding the potential value of Whole Genome Sequencing (WGS) in establishing genetic diagnosis. The study will examine diagnosis rates, changes in clinical care as a result of a genetic diagnosis, health economics including potential cost-effectiveness of WGS and patient and provider experience with genomic medicine.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (4 items).

Location: Nickalus Children's Hospital f/k/a Miami Children's Hospital — Miami, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Symptomatic male or female children ages 0-21 who have un unknown medical condition thought to have an underlying genetic cause after parental consent has been obtained.
Willingness of referring provider or other qualified medical staff member to participate in this study by facilitating collection of biologic specimens and clinical information.
Patient whose medical condition can be reasonably attributed to a possible genetic etiology.
Patient have had at least one diagnostic test without a definite diagnosis.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Unwillingness to consent to research.
Affected adults (\>21 years of age), unless they are a biological relative of the affected child.
Any patient whose medical condition cannot be reasonably attributed to a possible genetic etiology or there is a prior diagnosis that explains the child's clinical presentation.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Nickalus Children's Hospital f/k/a Miami Children's Hospital — Miami, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗