None listed
Conditions
Brief summary
This study aims to identify the optimal way to implement fluoropyrimidine chemotherapy in patients who have a genetic variant of the DPYD gene, the ability to test for UGT1A1 prior to irinotecan chemotherapy, and cost effectiveness of a large-scale roll out of this screening program. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have solid organ malignancy requiring fluoropyrimidine chemotherapy. You may be eligible for additional for UGT1A1 genotyping if you require irinotecan chemotherapy Study details All participants who meet the eligibility criteria in this study will undergo pharmacogenomic (PGx) genotyping to identify DPYD and UGT1A1 variants prior to commencing Fluoropyrimidine (FP) and Irinotecan (IRI)(where applicable) chemotherapies. Genotyping is conducted from a blood sample collected from patients prior to commencing chemotherapy, and relevant adjustments to chemotherapy dosing is made in accordance with international dosing guidelines. Participants will be followed for 60 days to assess for acute chemotherapy induced toxicity, and beyond completion of chemotherapy regimen to assess cost-effectiveness and feasibility of the screening program. No additional tests will be required from patients beyond standard of care. It is hoped that this research project will determine the feasibility of DPYD genetic testing for cancer patients which may assist with providing personalised treatment options for these patients.
Interventions
Single arm interventional prospective study.
Patients with solid organ cancers undergo pharmacogenomic (PGx) genotyping to identify dihydropyrimidine dehydrogenase (DPYD) and UDP glucuronosyltransferase family 1 (UGT1A1) variants prior to commencing Fluoropyrimidine (FP) and Irinotecan (IRI) (where applicable) chemotherapies. All possible FP and IRI chemotherapy regimens are accepted (regardless of dosing and dose intervals). Both intravenous and oral FP regimens are included.
Genotype status
Single arm interventional prospective study. Patients with solid organ cancers undergo pharmacogenomic (PGx) genotyping to identify dihydropyrimidine dehydrogenase (DPYD) and UDP glucuronosyltransferase family 1 (UGT1A1) variants prior to commencing Fluoropyrimidine (FP) and Irinotecan (IRI) (where applicable) chemotherapies. All possible FP and IRI chemotherapy regimens are accepted (regardless of dosing and dose intervals). Both intravenous and oral FP regimens are included. Genotype status is determined by blood test to be taken prior to commencing chemotherapy.This can be taken at any time prior to commencement of treatment, but sooner is better to allow adequate laboratory processing time. Typical turn around is 5 business days. Patients found to have a DPYD variant undergo an FP dose reduction (as per international guidelines) to reduce toxicity and improve tolerability. No other alterations to dose interval or regimen are expected. Patients will be monitored for 60 days post first exposure via routine clinic visits, and chemotherapy related toxicities will be recorded. UGT1A1 genotyping is for feasibility analysis only, IRI dose adjustments to be made at clinician discretion.
Sponsors
Hunter Medical Research Unit
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Minimum 18 years old Solid organ malignancy requiring fluoropyrimidine chemotherapy (+/- irinotecan for UGT1A1 genotyping) Able to provide informed consent Able to provide blood sample
Exclusion criteria
Prior fluoropyrimidine exposure Pregnant or breastfeeding women Unwilling to provide consent and/ or blood sample
Outcome results
None listed