This is a non-therapeutic clinical trial that is only open to St. Jude patients
Description
Pharmacogenetics is the study of how genes affect a person’s response to drugs. This field combines pharmacology (the science of drugs) and genetics (the study of genes and their functions) with the goal of making medications safer and more effective by tailoring medications based on a person’s genetic makeup (https://CPICpgx.org).
Gene tests are used in pharmacogenetics. Over time, scientists are discovering which of these gene tests are so important that they should move from the research lab into the patient’s medical record, where they would be available to the doctors and other care givers to see the test results, and to use the information when they give the patient the drug.
The process for deciding which tests to move from the research lab into the patient medical record is not well defined. Right now, genetic tests are not being used as much as they could be to help decide which drugs and doses are right for the patient. This study will help us set up processes so we can choose which of the gene tests are important enough to be put in patient medical record. This study will see how doctors, patients, and their families accept the process.
As of June 2020, PG4KDS pharmacogenetic test results were being used in the health records for nearly 6,000 St. Jude patients.
Objectives
- Test each patient for hundreds of gene variations that might be important for drug use. All of the gene test results will be in the research laboratory, but as time goes on, the study will evaluate scientific evidence and selectively move test results for a few genes into the medical record if the evidence strongly shows that the result can help in better prescribing of drugs for patients
- Estimate how often pharmacogenetic test results are moved from research tests into a patient’s medical record.
- Use methods to choose which of these tests should be put in the medical record.
- Use computer-based tools in the electronic medical record to help doctors use gene test results when prescribing drugs.
- Share feelings and concerns of patients and their families about gene test information being put in their medical record.
Eligibility
Inclusion Criteria
- Accepted for treatment for active disease as a St. Jude patient, evidenced by matriculation with a St. Jude medical record number, and with the St. Jude medical record as the primary medical record for the patient
Exclusion Criteria
- Past history of allogeneic hematopoietic stem cell transplant (or other condition that would result in blood DNA failing to match host tissue DNA).
- Attending physician objection to enrollment.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Current Priority (Clinically Eligible) Genes
Priority genes are those whose variants are so closely linked to medication effects that they meet our criteria for being moved from the research laboratory into the patient medical record. Once the gene results are in the medical record, they can then be used by doctors, pharmacists, nurses, and other clinicians to make decisions about drug therapy.
There may be hundreds or thousands of different gene variations that are important to drug use. One of the primary goals of the PG4KDS study is to decide which of these variations should actually be used for care of patients; we will work on the process of taking information that we learn from research and use it to make medications more effective and safer in patients.
As knowledge advances, new genes (and the medications they affect) will be added to our priority list. This process will be deliberate: gene-by-gene and drug-by-drug. As new priority genes are implemented, it will be our goal to keep the St. Jude patients and families well-informed on what that knowledge will mean for them.
For every gene, every person inherits one copy of the gene from their mother and one from their father; the combination of the two copies of each gene is called the “genotype” (or diplotype) for that gene. In PG4KDS, “priority genotypes” are linked in the medical record with special alerts, so that medications affected by the gene will be matched to the genotype information.
See More Information on this page for a brief description of each priority gene that is currently being used to make drug therapy decisions for patients on the St. Jude PG4KDS study.
