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Bowel cancer screening participation rate in a program that offers blood tests as well as faecal tests as screening options.

Will people from the general population, who are offered a bowel cancer screening program that includes a blood test in addition to faecal occult blood test, participate at a significantly greater rate relative to people offered a screening program consisting of faecal tests only?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000972527
Enrollment
1800
Registered
2015-09-17
Start date
2016-04-29
Completion date
2016-05-10
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to determine whether offering a screening blood test to people who do not participate with standard faecal-based testing method can increase overall bowel cancer screening participation compared to a program that only offers a faecal occult blood test (FOBT). Who is it for? Participants for this study will be randomly selected from the South Australian electoral roll, all between 50 and 74 years of age, who have not had an FOBT or colonoscopy carried out in the last 12 months. Study details: All participants will be mailed an offer for FOBT, with a reminder letter sent 6 weeks later to non-participants. For those who will not or can not complete the FOBT, they will be randomly allocated (by chance) to receive an immediate offer of screening with a new blood test, or after 12 weeks will receive either another offer for screening with FOBT, or an offer to screen with the blood test. Additional reminder letters will be sent another 6 weeks later to non-participants. A second round of screening offers will be provided in Round 2 of the study 24 months after initial invitation. For the participants who completed either the blood test or FOBT in the first round of the study, they will be offered the same test again to assess adherence to screening. For those who did not complete any test in the first round of the study, they will be randomly allocated (by chance) an offer to screen with the blood test, the FOBT, or have a choice of the tests. Reminder letters will be sent after 6 weeks to people who have not completed a test. Rates of participation with the different tests will be determined 12 weeks after the screening offer. It is hoped that the findings of this trial will aid understanding of whether a screening test for bowel cancer by blood test rather than faecal testing methods shows greater participation rates as well as adherence to ongoing screening, and thus whether this alternative method shows potential for reducing mortality from bowel cancer in the long term.

Interventions

The intervention is a bowel cancer screening program that includes the availability of a screening blood test after an offer of the standard faecal occult blood test (FOBT). There are two intervention groups (n = 600 per group). Everyone in the intervention will be initially mailed an offer of screening for bowel cancer by FOBT. For the first intervention group, after 12 weeks anyone who has not participated with the FOBT will be mailed an offer of screening for bowel cancer by blood test (the

The intervention is a bowel cancer screening program that includes the availability of a screening blood test after an offer of the standard faecal occult blood test (FOBT). There are two intervention groups (n = 600 per group). Everyone in the intervention will be initially mailed an offer of screening for bowel cancer by FOBT. For the first intervention group, after 12 weeks anyone who has not participated with the FOBT will be mailed an offer of screening for bowel cancer by blood test (the methylated BCAT1/IKZF1 blood test). They will then need to call the study helpline to request a further blood test information. The second intervention group will be sent the offer for the blood test at the same time as receiving the FOBT. They will be advised that if they believe that the FOBT is not suitable for them they might consider screening for bowel cancer by blood test. They will then need to call the study helpline to request a further blood test information. Anyone requesting the blood test will then be sent information about the test (including 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 10 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 to non-participants 6 weeks after each type of screening test offer. Participants of the FOBT will be required to collect a small sample from two separate bowel movements. These samples are then sent via reply-paid mail to a laboratory which tests the samples for the presence of blood. If more than 100ng/mL of blood is present in either sample, than the participant will be sent a positive result letter (which will be copied to their GP) to advise further investigations. Participants of the blood test will need to attend a Healthscope collection centre and have 18mL of blood collected. This will be sent to a laboratory for analysis. If methylated BCAT1 or IKZF1 are detected in the blood sample then the participant will be sent a positive result letter (which will be copied to their GP) to advise further investigations. Total screening participation rate with either the FOBT or the blood test will be assessed at 24 weeks after the start of the study (12 weeks after the blood test offer). Round 2: to examine participation and re-participation over two rounds of colorectal cancer screening offers. The same cohort (participants and non-participants who did not withdraw/opt-out from the study) will be contacted in this Round. This will assess whether non-participants can be encouraged to participate by offering more choice of test up front, thereby ‘rescuing’ people who may not participate from a single screening offer, or from a FOBT offer only. Round 3: In Round 1 and 2, participants were enrolled into the study and offered either a blood test or an FOBT bowel cancer screening test. After all participants were enrolled and the results were analysed, approximately 100 participants were found to have a positive bowel cancer screening result. These 100 participants, and their General Practitioners, were sent a letter informing them of their positive result with a recommendation to consider further investigation for colorectal cancer (CRC) screening, by way of a colonoscopy (which is the gold standard). We would now like to determine how many participants have had follow-up investigations after a positive CRC screening test, and further evaluate diagnostic accuracy of each test type.

Sponsors

Erin Symonds
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

Randomly selected South Australians from the Australian Electoral Roll, aged 50-74y.

Exclusion criteria

- Already up-to-date with screening (i.e. have completed a FOBT or had colonoscopy within the last 12 months) - Unable to provide informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026