Bowel Cancer Screening with a Blood Test.

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000299505

Enrollment

240

Registered

2015-03-31

Start date

2015-04-21

Completion date

2015-09-21

Last updated

2020-01-13

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

50 Years to 74 Years

Healthy volunteers

Yes

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).

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)

Outcome results