Cyclophosphamide bioactivation pharmacogenetics in breast cancer patients.
Nuala Helsby, Minghan Yong, Kathryn Burns...
https://pubmed.ncbi.nlm.nih.gov/34114066Actively Recruiting
Phase 1
Age: 6Years - 25Years
All Genders
ID06383338
A Prospective Feasibility Study Investigating Phenoconversion of CYP3A4, CYP2C19, and CYP2D6 Genotype in Pediatric and Young Adult Patients With Hodgkin or Non-Hodgkin Lymphoma
Led by Murdoch Childrens Research Institute · Updated on 2025-09-08
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the acceptability and feasibility of studying phenoconversion, which is the change in metabolism phenotype, using probe medications in children, adolescents, and young adults aged 6 to 25 years diagnosed with Hodgkin lymphoma or non-Hodgkin lymphoma. This phase 1 study focuses on understanding how cancer and supportive care medicines metabolized by the CYP3A4, CYP2C19, and CYP2D6 pathways behave in this population. The findings will help guide more personalized precision medicine approaches in pediatric cancer treatment. Participants will receive sub-therapeutic doses of probe drugs, specifically omeprazole and dextromethorphan, administered orally or via nasogastric tube during scheduled hospital visits aligned with their lymphoma treatment. Blood samples will be collected at baseline and at longitudinal timepoints up to 24 months to measure the metabolism of these probe drugs and assess phenoconversion over time. During the study, participants will undergo blood draws and complete surveys assessing the acceptability of pharmacogenomic and phenoconversion testing. Researchers will monitor metabolic ratios, inflammatory markers, medication use, and adverse events related to probe drug administration. The study duration includes baseline and multiple follow-up assessments over 24 months to evaluate metabolism changes and feasibility of this approach in pediatric oncology patients.
CONDITIONS
Brief Title
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.
Who Can Participate
Age: 6Years - 25Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 6 to 25 years
- New diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma
- Able to swallow or receive oral/nasogastric tube administration of probe drugs
- Able to provide written informed consent
You will not qualify if you...
- Failure to meet inclusion criteria
- Known allergy to omeprazole or dextromethorphan
- Severe organ dysfunction (CTCAE Grade IV) affecting liver, kidneys, or gastrointestinal system
- Previous cancer treatment (not first diagnosis)
- Clinically unstable requiring intensive care
- Urgent cancer treatment initiation outside study staff hours preventing consent
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 months
Participants receive sub-therapeutic probe drugs (omeprazole and dextromethorphan) to measure metabolism phenotype changes over time.
Baseline and at least two longitudinal visits over 24 months
Trial Site Locations
Total: 1 location
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Loading map...
Research Team
R
Rachel Conyers, MBBS (Hons)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
CYP2C19 genotype-phenotype discordance in patients with multiple myeloma leads to an acquired loss of drug-metabolising activity.
K E Burns, M A Goldthorpe, F Porteus...
https://pubmed.ncbi.nlm.nih.gov/24519754Interleukin-6 and cytochrome-P450, reason for concern?
Sooha Kim, Andrew J K Östör, Muhammad K Nisar
https://pubmed.ncbi.nlm.nih.gov/22451032Practice of CYP450 genotyping and phenotyping in children in a real-life setting.
Frédérique Rodieux, Youssef Daali, Victoria Rollason...
https://pubmed.ncbi.nlm.nih.gov/36937881Geneva cocktail for cytochrome p450 and P-glycoprotein activity assessment using dried blood spots.
M Bosilkovska, C F Samer, J Déglon...
https://pubmed.ncbi.nlm.nih.gov/24722393Screening for genotypic and phenotypic variations in CYP450 activity in patients with therapeutic problems in a psychiatric setting, a retrospective study.
Célia Lloret-Linares, Victoria Rollason, Kuntheavy Ing Lorenzini...
https://pubmed.ncbi.nlm.nih.gov/27378571Evaluation of Phenotypic and Genotypic Variations of Drug Metabolising Enzymes and Transporters in Chronic Pain Patients Facing Adverse Drug Reactions or Non-Response to Analgesics: A Retrospective Study.
Victoria Rollason, Célia Lloret-Linares, Kuntheavy Ing Lorenzini...
https://pubmed.ncbi.nlm.nih.gov/33121061CYP450 Genotype-Phenotype Concordance Using the Geneva Micrococktail in a Clinical Setting.
Kuntheavy Ing Lorenzini, Jules Desmeules, Victoria Rollason...
https://pubmed.ncbi.nlm.nih.gov/34512355Prediction of cytochromes P450 3A and 2C19 modulation by both inflammation and drug interactions using physiologically based pharmacokinetics.
Camille Lenoir, Amine Niederer, Victoria Rollason...
https://pubmed.ncbi.nlm.nih.gov/34791831Blood and Plasma Volumetric Absorptive Microsampling (VAMS) Coupled to LC-MS/MS for the Forensic Assessment of Cocaine Consumption.
Roberto Mandrioli, Laura Mercolini, Michele Protti
https://pubmed.ncbi.nlm.nih.gov/32110941