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Trial registered on ANZCTR


Registration number
ACTRN12615000299505
Ethics application status
Approved
Date submitted
18/03/2015
Date registered
31/03/2015
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel Cancer Screening with a Blood Test.
Scientific title
Effectiveness of offering a blood test screening service to individuals who are at higher risk for developing bowel cancer and are not willing/able to undergo screening with a faecal occult blood test on bowel cancer screening participation.
Secondary ID [1] 286376 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 294518 0
Condition category
Condition code
Public Health 294823 294823 0 0
Health service research
Cancer 294824 294824 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible people (n = 240) within the SCOOP program (a colonoscopy surveillance program for individuals at higher risk for bowel cancer) at Repatriation General Hospital or Flinders Medical Centre who do not screen for bowel cancer via the standard means (ie. faecal testing), will be sent a letter to invite them to screen for bowel cancer with a blood test (Colovantage Plasma), as well as a short survey to ascertain their demographic details and their screening history. Anyone interested in taking up the blood screening test will be asked to fill in the consent form and request form and send them back (in the provided reply paid envelope) to the Bowel Health Service. Following receipt of the blood test request form, the study enrolee will then be sent further information on the blood test (including information on the accuracy of the test, where they can get their blood collected, and when they will receive their test results) and a test referral. They can then take up the offer of the free screening blood test at one of four local blood collection centres (Healthscope). They do not need to be fasted and appointments do not need to be made. Reminder letters will be sent after 6 weeks to those people who have not taken up the blood test screening offer. Screening participation rate with the blood test and demographic factors that influence uptake, will be assessed at the 12 week time point.
Intervention code [1] 291440 0
Early detection / Screening
Comparator / control treatment
All study invitees will be offered screening with the new blood test and factors (eg. age, gender) that influence screening uptake will be assessed. The comparison group will be those that do not participate in screening.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294587 0
The primary outcome is to determine how many people within 12 weeks following the invitation letter have a blood sample collected for bowel cancer screening (ie. outcome = blood test participation rate). The number that complete the blood test will be expressed as a percentage of the invited cohort (ie. 240)
Timepoint [1] 294587 0
12 weeks after invitation to screen.
Primary outcome [2] 294588 0
An additional primary outcome will be to determine the factors that predict screening uptake with the blood test, ie. age, gender, risk status for bowel cancer, reasons for not participating with faecal testing. This information will be established via a short survey (designed specifically for this study) that is provided with the original study invitation letter.
Timepoint [2] 294588 0
12 weeks after invitation to screen.
Secondary outcome [1] 313675 0
A secondary outcome will be to determine if the use of a reminder letter after 6 weeks will encourage further completion of the blood test for bowel cancer screening and whether this additional is dependent on demographic factors such as gender and age. The number of people in each of the gender/age subgroups that complete the blood test before and after the reminder letter will be compared at the 12 week time point.
Timepoint [1] 313675 0
12 weeks after invitation to screen.
Secondary outcome [2] 313676 0
An additional secondary outcome is to determine how many people have a positive blood test result out of the people that took up the offer of a screening test. A positive blood test result is defined as the presence of either hypermethylated BCAT1 or IKZF1 in the plasma sample (using quantitative real time PCR). As everyone who has a positive blood test result will be recommended to undergo a colonoscopic investigation, we will then be able to determine the accuracy of a positive blood test result for diagnosing the presence of colorectal cancer (based on the findings from colonoscopy).
Timepoint [2] 313676 0
6 months after invitation to screen.

Eligibility
Key inclusion criteria
- Male or female aged between 50 and 74 years (inclusive)
- Within the SCOOP population (ie. are at higher risk for developing bowel cancer)
- Do not participate with faecal screening tests due to either personal reasons or medical reasons (ie. contraindicated for FIT by their specialist due to a bleeding condition of the bowel, including haemorrhoids, radiation proctitis, diverticular disease and angiodysplasia).
Minimum age
50 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unable to provide informed consent
- Due for colonoscopy within the same calendar year
- Have had colonoscopy in the preceding 6 months
- Offered or completed a faecal screening test in the previous 12 months
- Otherwise deemed unsuitable for screening offer by the specialist (eg. poor English language comprehension or inability to follow protocol)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
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)
SA

Funding & Sponsors
Funding source category [1] 290948 0
Charities/Societies/Foundations
Name [1] 290948 0
The Repat Foundation
Address [1] 290948 0
216 Daws Road
Daw Park
South Australia 5041
Country [1] 290948 0
Australia
Funding source category [2] 290949 0
Charities/Societies/Foundations
Name [2] 290949 0
Flinders Medical Centre Foundation
Address [2] 290949 0
1 Flinders Drive
Bedford Park
South Australia 5042
Country [2] 290949 0
Australia
Primary sponsor type
Individual
Name
Erin Symonds
Address
Bowel Health Service, Building 40
Repatriation General Hospital
216 Daws Road
Daw Park
South Australia 5041
Country
Australia
Secondary sponsor category [1] 289630 0
None
Name [1] 289630 0
Address [1] 289630 0
Country [1] 289630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292548 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 292548 0
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park
Sout Australia 5042
Ethics committee country [1] 292548 0
Australia
Date submitted for ethics approval [1] 292548 0
21/11/2014
Approval date [1] 292548 0
22/01/2015
Ethics approval number [1] 292548 0
485.14

Summary
Brief summary
This study aims to determine how many people who are unsuitable for screening with the faecal occult blood test (FOBT) will take up bowel cancer screening with the new blood test instead.
Who is it for? You may be eligible to join this study if you are aged between 50 and 74 years (inclusive), are at higher risk of developing bowel cancer and are unwilling or unable to participate in faecal screening tests for bowel cancer due to either personal or medical reasons.
Study details: Bowel cancer screening is typically achieved with a FOBT which detects small amounts of blood in faeces. While this form of screening has been shown to be effective at detecting cancer at an early and more treatable stage, there are many people in the community who are unable to complete the screening test. This can be due to a dislike of sampling from faeces, or due to a condition that causes bleeding from the bowel (such as haemorrhoids) which would interfere with the results of the FOBT. We have recently developed a new form of screening for bowel cancer with a blood test which could provide an appropriate means of testing for these individuals.
In our study we will determine how many people who are unsuitable for FOBT testing will take up bowel cancer screening with the new blood test instead. We will also determine what factors may influence their decision on whether to complete a screening test. As part of the study we will provide the participants (and their GPs) with their test result, and advice on further medical investigations should they test positive. A better understanding of how to provide better screening options for people at higher risk for bowel cancer is important and could have significant implications for public health practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55870 0
Dr Erin Symonds
Address 55870 0
Bowel Health Service, Building 40
Repatriation General Hospital
216 Daws Road
Daw Park
South Australia 5041
Country 55870 0
Australia
Phone 55870 0
+61 08 82751070
Fax 55870 0
Email 55870 0
Erin.Symonds@health.sa.gov.au
Contact person for public queries
Name 55871 0
Dr Erin Symonds
Address 55871 0
Bowel Health Service, Building 40
Repatriation General Hospital
216 Daws Road
Daw Park
South Australia 5041
Country 55871 0
Australia
Phone 55871 0
+61 08 82751070
Fax 55871 0
Email 55871 0
Erin.Symonds@health.sa.gov.au
Contact person for scientific queries
Name 55872 0
Dr Erin Symonds
Address 55872 0
Bowel Health Service, Building 40
Repatriation General Hospital
216 Daws Road
Daw Park
South Australia 5041
Country 55872 0
Australia
Phone 55872 0
+61 08 82751070
Fax 55872 0
Email 55872 0
Erin.Symonds@health.sa.gov.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