VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey
Completed · Not applicable
Conditions studied: Pharmacogenomic Testing
In brief
The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. The unique physiology of childhood and pregnancy demand validation of pharmacogenetic signals prior to clinical implementation. These knowledge gaps are compounded for individuals from minority populations, who have been underrepresented and thus underserved by genomic research and specifically pharmacogenetic studies. The primary objective of this project is to advance research and support clinical implementation in pharmacogenetics for children and pregnant women. This work will illuminate knowledge of, attitudes about, and priorities for pharmacogenetics, and will assess the impact of a brief educational video on knowledge and attitudes around pharmacogenetic testing. The investigators will assess the knowledge and attitudes regarding pharmacogenetic testing among diverse cohorts of children with chronic conditions and pregnant women, before and after receiving pharmacogenetic test results. Participants will be randomized to view an educational video about pharmacogenetic testing either at the time of receiving their pharmacogenetic test results, or at a later time. The investigators will perform surveys before and after pharmacogenomic testing and return of results, and before and after watching the educational video.
Key facts
- Study ID
- NCT05037305
- Run by
- Vanderbilt University Medical Center
- People needed
- 798
- Starts
- 2022-06-30
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2026-06-12
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Provide consent in English or Spanish
- Primary care at VUMC
- Adult women aged 18 and older
- Currently pregnant 12 to 30 weeks gestational age
- Completed or scheduled first prenatal visit at VUMC clinic
- Intent to deliver at VUMC or affiliate
- Agrees to receive findings from pharmacogenomic testing
- Allow access their medical record
You may not qualify if…
- Stem cell or solid organ transplant
- Recent transfusion within the previous 2 months
- Inability to provide DNA sample for testing
- Prior pharmacogenomic testing
- Pregnant women undergoing in vitro fertilization or assisted reproductive technologies
- Pediatric
- Inclusion Criteria:
- Provide consent (parent/guardian) and/or assent (child) in English or Spanish
- Primary care or subspecialty care at VUMC
- Aged 0 to 16
- Parent (0-16 years) and child (12-16 years) agree for both parent and child to receive findings from pharmacogenomic testing
- Parent (0-16 years) and child (12-16 years) allow access their medical record
- Have a chronic health condition.
- Exclusion:
- Stem cell or solid organ transplant
- Recent transfusion within the previous 2 months
- Inability to provide DNA sample for testing
- Prior pharmacogenomic testing
Where it is running
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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