<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2017</study_start_year><condition>Cancer-Breast</condition><condition>Cancer-Bowel-Back passage (rectum) or large bowel (colon)</condition><condition>Gastrointestinal (GI) cancer</condition><condition>Cancer-Bowel-Anal</condition><condition>Breast cancer</condition><condition>Cancer-Bowel-Small bowel (duodenum and ileum)</condition><condition>Cancer-Stomach</condition><disease>Cancer-bowel-anal</disease><disease>Cancer-bowel-small Bowel (duodenum And Ileum)</disease><disease>Cancer-stomach</disease><disease>Gastrointestinal (gi) Cancer</disease><disease>Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)</disease><disease>Breast Cancer</disease><disease>Cancer-breast</disease><study_type>Observational</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2465876</full_dataset_link><location>New Zealand</location><study_start_month>11</study_start_month><repository>ECRIN MDR</repository><study_status>Completed</study_status></additional><is_claimable>false</is_claimable><name>An observational study to assess the ability of the thymine loading test to prospectively categorise patients with gastrointestinal or breast cancer who cannot tolerate fluoropyrimidine treatment.</name><description>Interventions: This study is an observational study. Thymine test results will not affect any treatment decisions. 
At a scheduled assessment clinic visit, >24 hours prior to the commencement of treatment with 5-FU/capecitabine containing schedules:
A baseline blood sample will be obtained (one 10 ml sample) as well as a baseline spot urine sample. A cheek (buccal) cell sample will also be obtained. This will involve using a cytobrush to take a brushing of the inside of the cheek (like using a toothbrush on the inside of the mouth). This will be done twice (one on each side of the mouth) and will require a mouth wash with water prior to the first brushing. The participants will then be administered thymine (250 mg, oral gelatine capsule) with a drink of water. A cumulative (total) urine sample will be collected for the next 4 hours. 
All patients who have been given the thymine test will then continue on their planned chemotherapy treatment. All patients will be assessed for adverse events related to 5-FU/capecitabine treatment. Information will be collected at each scheduled clinic visit for 8 – 9 weeks while on normal chemotherapy treatment.
Analysis will involve urine sample for thymine and its metabolite (dihydrothymine or DHT). Cheek cells will be used to assess 5-FU uptake in vitro and genomic DNA (from blood) will be used to analysing variation in the DPYD gene and further analysis of genes associated with 5-FU side effects.
Primary outcome(s): The primary outcome is the presence of severe DM toxicity. All diarrhoea (D) and mucositis (M) toxicities will be identified and coded according to CTCAE criteria. Patients with grade 2 or less GI events or haematotoxicity, or grade 1 or less hand-foot syndrome will be coded as minimal toxicity. For patients with a Grade 3 or higher D or M toxicity a review will be carried out by a clinical PI (blinded to thymine test results and genomic information).[Information will be collected at each scheduled clinic visit for 8 – 9 weeks while on normal chemotherapy treatment.
]
Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective</description><dates><creation>2017-11-15</creation></dates><accession>2465876</accession><cross_references><Australian New Zealand Clinical Trials Registry>ACTRN12617001109392</Australian New Zealand Clinical Trials Registry></cross_references></HashMap>