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PREDICT Fluorouracil (5-FU): A Study to Describe the Feasibility of Therapeutic Drug Monitoring of 5-FU in Cancer Treatment

ABSTRACT: Interventions: Patients prescribed 5-FU/Capecitabine as part of their standard of care treatment will provide an additional 2 blood samples and a single dried blood spot for therapeutic drug monitoring. Samples will be collected by either doctor, research nurse or pathology collector. The first sample is collected at the patient’s screening visit with other routine blood samples. The second sample will be collected additionally during the patient’s treatment and will require 10 minutes for collection. Levels of drug will be provided back to clinician and dose of 5-FU/Capecitabine may change based on individual clinicians clinical judgement. The level of drug in blood sample will be correlated with level of drug in dried blood spot for feasibility of using dried blood spot and/or whole blood samples for ongoing therapeutic drug monitoring of 5-FU/Capecitabine. The change (is applicable) and outcome will be collected. Primary outcome(s): The feasibility of pK testing will be determined by the amount of samples analysed for 5-FU. [Patients will be assessed at day 1, cycle 1 post registration chemotherapy.];Determination of AUC.[Blood sample during treatment - 18 hours after the start of 5fu infusion.] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Pharmacokinetics

DISEASE(S): Gastrointestinal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Head And Neck Cancer,Breast Cancer,Cancer-breast,Cancer-head And Neck

PROVIDER: 2471364 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Standard Guthrie cards have been widely used to collect blood samples from neonates for newborn screening programs, and to a lesser extent, from normal controls and patients in research studies. Ease of blood collection (small quantity and less pain), transportation, and storage are the advantages of using these cards. It is believed that RNA obtained from these samples is of low quantity and degraded quality. However, we recently discovered that approximately 3,500 expressed genes can be detected from blood spot samples using in-house made, low resolution cDNA microarrays. Here, we established a new and improved methodology to acquire gene expression profiles from blood spot cards using commercially-available high resolution microarrays. We determined the optimal number of blood spot punches required for maximal RNA extraction, eliminated uses of trizol and chloroform for RNA extraction by using a modified protocol of the illustra Mini Spin Kit from GE-Whatm an, concentrated the quantity of RNA templates before amplification, improved amplification efficiency using the new Ribo-SPIA technology in WT-Ovation Pico System (WT-Pico) by NuGEN, before the samples were hybridized onto 4x44K whole human genome gene expression microarrays from Agilent. Nine dried blood spot samples were collected from a control population and stored at ~ -80 °C between 6 months to 2 years. High quality RNA was extracted from the buffy coat of the same individuals as a reference and processed using the standard Agilent microarray procedure. Commercially-available brain RNA was used as a positive control in both standard and new procedures for microarrays. Results: Three 3-mm punches produced the highest yield of total RNA using the non-trizol extraction method. Three to six nanogram per microliter of RNA can be concentrated and is sufficient to be amplified using the WT-Pico. Approximately 9,000 expressed genes can be detected after normalization and background correction of the microarray data. Conclusion: Genome-wide gene expression profile can be obtained from archived dried blood spot samples. Our new and improved methodology will add value to the perception of utilizing archival Guthrie cards eg. neonatal blood spot cards as unique biospecimens for molecular genomics and diagnostic studies of perinatal diseases such as pediatric cancers. Keywords: Gene Expression experiment

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PREDICT Fluorouracil (5-FU): A Study to Describe the Feasibility of Therapeutic Drug Monitoring of 5-FU in Cancer Treatment

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