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Trial registered on ANZCTR


Registration number
ACTRN12608000268347
Ethics application status
Approved
Date submitted
20/05/2008
Date registered
28/05/2008
Date last updated
9/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The ability of a uracil breath test and a thymine loading test to correctly identify patients who have experienced severe 5-Fluorouracil (5FU) toxicity.
Scientific title
The ability of a uracil breath test and a thymine loading test to correctly identify patients who have experienced severe 5-Fluorouracil (5FU) toxicity in patients with colorectal cancer.
Secondary ID [1] 287833 0
nil known
Universal Trial Number (UTN)
Trial acronym
DPD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
5-Fluorouracil toxicity 3172 0
Condition category
Condition code
Cancer 3331 3331 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
uracil breath test (once off test), thymine assay of saliva, blood and urine, genetic analysis of blood. The testing will be completed over 2 days once informed consent is signed. These tests are not standard practice. The testing will be done on patient who exeprienced 5FU toxicity up to 1 year ago.
Intervention code [1] 2904 0
Diagnosis / Prognosis
Comparator / control treatment
cohort of patients without 5FU toxicity
Control group
Active

Outcomes
Primary outcome [1] 4218 0
To determine the proportion of patients with severe 5FU toxicity have (a) abnormal Uracil breath test results and (b) abnormal thymine loading tests in saliva and urine
Timepoint [1] 4218 0
12 months post testing
Secondary outcome [1] 7135 0
to determine the proportion of patients with severe 5FU toxicity have common mutations in the gene responsible for the enzyme which breaks down 5-FU; dihydropyrimidine dehydrogenase (DPD) from a blood sample
Timepoint [1] 7135 0
12 month post testing

Eligibility
Key inclusion criteria
Have recieved a solely 5FU based chemotherapy treatment in the past with severe toxicity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events; grade 3-4 toxicity in 2 or more catagories with at least one hematological and one non-hematological toxicity.
No clinically significant hepatic or renal impairment.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or breast feeding.
Any known inherited disorder of metabolism.
Any severe respiratory disorder.
Any acute or chronic gastrointestinal disorder interfering with absorption.
Inability to give written informed consent.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3405 0
Hospital
Name [1] 3405 0
Southern Health, Monash Medical Centre
Address [1] 3405 0
246 Clayton rd
Clayton 3168
Country [1] 3405 0
Australia
Primary sponsor type
Hospital
Name
Southern Health, Monash Medical Centre
Address
Medical Oncology
865 Centre Rd
East Beltleigh 3165
Country
Australia
Secondary sponsor category [1] 3049 0
Hospital
Name [1] 3049 0
Southern Health, Monash Medical Centre
Address [1] 3049 0
Genetics Department
Familial Cancer Clinic
246 Clayton rd
Clayton 3168
Country [1] 3049 0
Australia
Other collaborator category [1] 291 0
Hospital
Name [1] 291 0
Mater Hospital
Address [1] 291 0
biochemistry department
Brisbane
Queensland
Country [1] 291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5434 0
southern health
Ethics committee address [1] 5434 0
246 Clayton Rd
Clayton 3168
Ethics committee country [1] 5434 0
Australia
Date submitted for ethics approval [1] 5434 0
22/04/2008
Approval date [1] 5434 0
29/07/2008
Ethics approval number [1] 5434 0
06060A

Summary
Brief summary
Trial completed with 6 subjects recruited. The breath test was not useful in predicting %FU toxicity. The Thymine test was useful in identifying soem patients with 5FU toxicity.
Trial website
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 28603 0
Dr Marion Harris
Address 28603 0
Monash Cancer Centre
865 Centre Rd
East Bentleigh
Country 28603 0
Australia
Phone 28603 0
61 3 9928 8120
Fax 28603 0
61 3 9928 8341
Email 28603 0
marion.harris@monashhealth.org
Contact person for public queries
Name 11760 0
Mr peter midolo
Address 11760 0
865 centre rd
east bentleigh
3165
Country 11760 0
Australia
Phone 11760 0
9928 8195
Fax 11760 0
9928 8543
Email 11760 0
peter.midolo@southernhealth.org.au
Contact person for scientific queries
Name 2688 0
Dr marion harris
Address 2688 0
865 centre rd
east bentleigh
3165
Country 2688 0
Australia
Phone 2688 0
9928 8120
Fax 2688 0
9928 8341
Email 2688 0
marion.harris@optusnet.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary