Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03911531 · ClinicalTrials.gov registry record
Whole Exome Sequencing and Whole Genome Sequencing for Nonimmune Fetal/Neonatal Hydrops
A clinical trial of Nonimmune Fetal Hydrops and Nonimmune Hydrops in Neonate, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- 55
- Enrollment target
- 1
- Study location
NCT03911531: Recruiting study of Nonimmune Fetal Hydrops and Nonimmune Hydrops in Neonate, sponsored by Thomas Jefferson University.
NCT03911531 is a study of Nonimmune Fetal Hydrops and Nonimmune Hydrops in Neonate that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 55 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03911531, a study of Nonimmune Fetal Hydrops and Nonimmune Hydrops in Neonate, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Brief Summary: Nonimmune hydrops fetalis (NIHF) is a potentially fatal condition characterized by abnormal fluid accumulation in two or more fetal compartments. Numerous etiologies may lead to NIHF, and the underlying cause often remains unclear (1). The current standard of genetic diagnostic testing includes a fetal karyotype and chromosomal microarray (CMA), with an option to pursue single gene testing on amniocytes collected by amniocentesis (2). A large subgroup of the NIHF causes includes single gene disorders that are not diagnosed with the standard genetic workup for hydrops. Currently, nearly 1 in 5 cases of NIHF is defined as idiopathic, meaning there is no identified etiology (2). The investigators believe this is because the causes of NIHF are not completely investigated, specifically single gene disorders. Our research study aims to increase the diagnostic yield by performing whole exome sequencing (WES) and whole genome sequencing (WGS) on prenatal and neonatal NIHF cases when standard genetic testing is negative, identifying known and new genes, thus providing vital information to families regarding the specific diagnosis and risk to future pregnancies. The investigators plan to perform WES as the initial diagnostic test. If WES is negative, then the investigators will proceed to perform WGS.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Whole Exome Sequencing
- DIAGNOSTIC_TEST Whole Genome Sequencing
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2028-12-31 |
What NCT03911531 shows while recruiting
NCT03911531 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.
The record links to 3 conditions, with Nonimmune Fetal Hydrops appearing as the primary indexed condition, and to 2 interventions - of which Whole Exome Sequencing is the first listed.
NCT03911531 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03911531 about?
NCT03911531 is a clinical study titled "Whole Exome Sequencing and Whole Genome Sequencing for Nonimmune Fetal/Neonatal Hydrops". Brief Summary: Nonimmune hydrops fetalis (NIHF) is a potentially fatal condition characterized by abnormal fluid accumulation in two or more fetal compartments. Numerous etiologies may lead to NIHF, and the underlying cause often remains unclear (1). The current standard of genetic diagnostic testin...
What is the current status of trial NCT03911531?
This trial is currently recruiting. The enrollment target is 55 participants. The study started on 2019-01-15. Estimated completion is 2028-12-31.
What conditions does trial NCT03911531 study?
This clinical trial studies the following conditions: Nonimmune Fetal Hydrops, Nonimmune Hydrops in Neonate, Genetic Disorders.
What interventions are being tested in trial NCT03911531?
The interventions under investigation include: Whole Exome Sequencing (DIAGNOSTIC_TEST), Whole Genome Sequencing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03911531?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03911531 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI