RECRUITING

VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women

Quick Facts

Study Start:2022-06-30
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05037305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide consent in English or Spanish
  2. * Primary care at VUMC
  3. * Adult women aged 18 and older
  4. * Currently pregnant 12 to 30 weeks gestational age
  5. * Completed or scheduled first prenatal visit at VUMC clinic
  6. * Intent to deliver at VUMC or affiliate
  7. * Agrees to receive findings from pharmacogenomic testing
  8. * Allow access their medical record
  1. * Stem cell or solid organ transplant
  2. * Recent transfusion within the previous 2 months
  3. * Inability to provide DNA sample for testing
  4. * Prior pharmacogenomic testing
  5. * Pregnant women undergoing in vitro fertilization or assisted reproductive technologies

Contacts and Locations

Study Contact

Sabrina E Holley, MD
CONTACT
6158754491
sabrina.e.holley@vumc.org
Sarah H Jones, MPH
CONTACT
6159363976
sarah.h.jones@vumc.org

Study Locations (Sites)

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • pharmacogenomic
  • PGx
  • pediatric
  • maternal

Additional Relevant MeSH Terms

  • Pharmacogenomic Testing