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Trial registered on ANZCTR


Registration number
ACTRN12615000586516
Ethics application status
Approved
Date submitted
20/04/2015
Date registered
4/06/2015
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Date results provided
7/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Thymine test for 5-fluorouracil side effects
Scientific title
An observational case-control study to detect predisposition to 5-fluorouracil/capecitabine-related toxicity using a thymine test in gastrointestinal cancer patients
Secondary ID [1] 286566 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal cancers 294818 0
Condition category
Condition code
Cancer 295091 295091 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 295092 295092 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 309416 309416 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants are administered a single dose of thymine (250 mg, orally) at any time prior to, or after completion of, a cycle of 5-fluorouracil/capecitabine treatment course.
A cumulative 4 h urine sample is collected for detemination of the amount of thymine and metabolites excreted
Intervention code [1] 291673 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294852 0
To determine whether the ratio of thymine to metabolites detected in the urine sample after the thymine test dose can discriminate between patients who tolerate 5-FU/capecitabine treatment and those who experience severe toxicity.
Timepoint [1] 294852 0
6 months
Secondary outcome [1] 314220 0
SNP variants of genes associated with abberrant 5-FU disposition, such as didhydropyrimidine dehydrogenase, will be assessed to detemine if any of these correlate with inter-individual differences in the thymine ratio detected in urine
Timepoint [1] 314220 0
6 months

Eligibility
Key inclusion criteria
Patients diagnosed with histologically confirmed gastrointestinal cancers or metastatic breast cancer; about to start or have commenced therapy with single agent 5FU or capecitabine
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breast feeding; concurrent adbominopelvic radiation therapy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2015
Actual
21/04/2015
Date of last participant enrolment
Anticipated
Actual
26/07/2017
Date of last data collection
Anticipated
Actual
26/08/2018
Sample size
Target
70
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 6833 0
New Zealand
State/province [1] 6833 0

Funding & Sponsors
Funding source category [1] 291127 0
Charities/Societies/Foundations
Name [1] 291127 0
School of Medicine Foundation, University of Auckland and Genesis Oncology Trust
Country [1] 291127 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland Private Bag 92019. Auckland Mail Centre Auckland 1142.
Country
New Zealand
Secondary sponsor category [1] 289803 0
None
Name [1] 289803 0
not applicable
Address [1] 289803 0
not applicable
Country [1] 289803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292706 0
Northern A Ethics Committee
Ethics committee address [1] 292706 0
Ethics committee country [1] 292706 0
New Zealand
Date submitted for ethics approval [1] 292706 0
Approval date [1] 292706 0
18/11/2014
Ethics approval number [1] 292706 0
14/NTA/186

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56198 0
A/Prof Nuala Helsby
Address 56198 0
Molecular Medicine and Pathology
FMHS, University of Auckland
85 Park Road,
Grafton
Auckland
Country 56198 0
New Zealand
Phone 56198 0
+6499239831
Fax 56198 0
Email 56198 0
n.helsby@auckland.ac.nz
Contact person for public queries
Name 56199 0
Nuala Helsby
Address 56199 0
Molecular Medicine and Pathology
FMHS, University of Auckland
85 Park Road,
Grafton
Auckland
Country 56199 0
New Zealand
Phone 56199 0
+6499239831
Fax 56199 0
Email 56199 0
n.helsby@auckland.ac.nz
Contact person for scientific queries
Name 56200 0
Nuala Helsby
Address 56200 0
Molecular Medicine and Pathology
FMHS, University of Auckland
85 Park Road,
Grafton
Auckland
Country 56200 0
New Zealand
Phone 56200 0
+6499239831
Fax 56200 0
Email 56200 0
n.helsby@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA simple ex vivo bioassay for 5-FU transport into healthy buccal mucosal cells.2019https://dx.doi.org/10.1007/s00280-019-03904-4
EmbaseA case-control study to assess the ability of the thymine challenge test to predict patients with severe to life threatening fluoropyrimidine-induced gastrointestinal toxicity.2020https://dx.doi.org/10.1111/bcp.14153
EmbaseComparison of a thymine challenge test and endogenous uracil-dihydrouracil levels for assessment of fluoropyrimidine toxicity risk.2021https://dx.doi.org/10.1007/s00280-021-04240-2
N.B. These documents automatically identified may not have been verified by the study sponsor.