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Genetic Testing
Neonate WGS Testing for Genetic Disorders (PISCES Trial)
N/A
Waitlist Available
Led By Gerard Vockley, MD, PhD
Research Sponsored by Jerry Vockley, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neonates: Greater than 24 weeks gestational age
Neonates: Birth weight greater than 600 grams
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
PISCES Trial Summary
This trial will study whether using whole genome sequencing can help doctors diagnose patients in an intensive care unit more quickly than with standard care testing.
Who is the study for?
This trial is for neonates in intensive care with suspected genetic disorders, over 24 weeks gestational age and weighing more than 600 grams. It's also open to their parents and necessary siblings. Neonates already diagnosed prenatally or with major congenital anomalies linked to chromosomal issues are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of whole genome sequencing (WGS) in diagnosing genetic conditions faster compared to standard testing in critically ill newborns. It will evaluate how WGS affects diagnosis time, patient outcomes, and healthcare costs.See study design
What are the potential side effects?
Since this trial involves diagnostic testing rather than a treatment intervention, there are no direct side effects like those associated with medications or therapies. However, there may be indirect consequences such as emotional impact from test results.
PISCES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born after more than 24 weeks of pregnancy.
Select...
My newborn weighs more than 600 grams.
PISCES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Care Cost Evaluation
Clinical Utility of WGS
Confirmed Diagnosis
+4 morePISCES Trial Design
1Treatment groups
Experimental Treatment
Group I: Neonate WGS TestingExperimental Treatment1 Intervention
Neonate subjects who are eligible and whose parents consent to study will undergo blood sampling which will be sent for whole genome sequencing and bioinformatics analysis, filtering first a targeted panel of 1722 genes most likely to cause genetic disorders in the first year of life, and then with a whole exome filter if no obvious diagnosis is determined using the 1722 gene panel filter.
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Who is running the clinical trial?
Jerry Vockley, MD, PhDLead Sponsor
4 Previous Clinical Trials
32 Total Patients Enrolled
Gerard Vockley, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
12 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My newborn has a diagnosed condition from prenatal testing.I have had genetic testing before but can still participate.My parent or guardian has given formal consent for me to participate.I have not participated in a similar study or matched as a control in the past 2 years.My newborn may have a genetic disorder, as suggested by their symptoms and tests, leading to a genetics consultation.My sibling can join the study even if they've had genetic testing before.My newborn's genetic test was done for reasons other than this study.My baby was born after more than 24 weeks of pregnancy.My newborn has a major birth defect linked to a chromosomal anomaly found in prenatal tests.My newborn weighs more than 600 grams.
Research Study Groups:
This trial has the following groups:- Group 1: Neonate WGS Testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to partake in this experiment?
"Clinicaltrials.gov reports that this clinical trial, first posted on July 13th 2020 and last amended on December 9 2021, is no longer recruiting participants; however, 57 other studies are actively seeking enrolment at the moment."
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