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Trial registered on ANZCTR


Registration number
ACTRN12618001406291
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
22/08/2018
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the diagnostic performance of faecal occult blood testing, against colonoscopy, in people at elevated risk for bowel cancer.
Scientific title
The value of interval faecal occult blood testing in colonoscopic surveillance programs for those at above-average risk for colorectal cancer.
Secondary ID [1] 295781 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 309203 0
Condition category
Condition code
Cancer 308074 308074 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 308075 308075 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Colorectal cancer (CRC) prevention programs are tailored to the degree of risk and within the Australian public health system with surveillance by colonoscopy usually reserved for those in the above average risk category. Different levels of risk, average, moderately increased and high, are recognised for population sub-groups. People with known genetic syndromes (eg familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC, also known as Lynch Syndrome] are considered to be at high risk for CRC and are advised to undergo regular (every 1-2 years) colonoscopic surveillance.

We propose to conduct this uncontrolled observational study, where patients self-select to the treatment group based on their participation in a colonoscopy surveillance program - the 'Southern Cooperative Program for the prevention of colorectal cancer' (SCOOP), run through Flinders Medical Centre and Noarlunga Hosptial. We will approach SCOOP patients and offer a FIT (Faecal Occult Blood Test) to be completed 1 - 2 weeks prior to their scheduled colonoscopy to determine the positive predictive value (PPV), negative predictive value (NPV), specificity and sensitivity for neoplasia of FIT, in comparison to colonoscopy.

The FIT kit including an invitation letter, two collection tubes, instructions and a reply paid envelope, will be posted to study invitees. Participants will be required to self-collect two small stool samples (approximately 10mg of stool which is smaller than a grain of rice) with the provided collection devices. The samples will then be placed in the collection tubes, placed in a reply paid envelope and posted back to the testing laboratory. Following return to the testing laboratory, samples will be analysed for levels of faecal haemoglobin. Testing will be within the Bowel Health Service Laboratory of Flinders Centre for Innovation in Cancer. The screening process is unlikely to lead to adverse medical events requiring contingency planning. Some participants may require further information or guidance through the testing process. The Bowel Health Service operates a business hours Help-Line to respond to any patient inquiries in relation to the study, eg the collection and return of specimens.

Faecal haemoglobin results will be compared to outcomes at colonoscopy which will allow for calculation of FIT accuracy for neoplasia detection.
Intervention code [1] 312112 0
Early Detection / Screening
Intervention code [2] 312114 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307066 0
Faecal haemoglobin level as assessed by FIT test.
Timepoint [1] 307066 0
assessed within 1 - 2 weeks before the colonoscopy
Secondary outcome [1] 350527 0
Severity of colonic lesions as assessed by colonoscopy.
Timepoint [1] 350527 0
assessed 1 - 2 days post colonoscopy procedure.

Eligibility
Key inclusion criteria
Patients enrolled in the SCOOP program. (patients assessed by the patient's hospital-based gastroenterologist as being at elevated risk for CRC and scheduled for colonoscopy)

Males and females aged 18 years of age or over.

Patients who are due for a colonscopy within the next month
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had bowel surgery and have a stoma in place.
Patients who have advised SCOOP that they would not like to receive a FIT.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Faecal haemoglobin concentration and severity of colonic lesions: Mann–Whitney U test for comparison between groups (lesion types) and median lesion size, multivariate analyses to allow for confounding variables. Receiver operating characteristic curves will be plotted to determine the diagnostic accuracy of FIT for adenomas and colorectal cancer (neoplasia). Sensitivity, specificity, negative predictive value and positive predictive value of FIT for neoplasia will be calculated at different faecal haemoglobin levels.

Recruitment
Recruitment status
Recruiting
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
Recruitment hospital [1] 11633 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 11634 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 23679 0
5042 - Bedford Park
Recruitment postcode(s) [2] 23680 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 300371 0
University
Name [1] 300371 0
The Flinders University of South Australia
Address [1] 300371 0
Flinders Centre for Innovation in Cancer
Bedford Park,
South Australia 5042
Country [1] 300371 0
Australia
Primary sponsor type
Individual
Name
Dr Erin Symonds
Address
Bowel Health Service
Flinders Centre for Innovation in Cancer
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 299885 0
None
Name [1] 299885 0
Address [1] 299885 0
Country [1] 299885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301183 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301183 0
SALHN Office for Research
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive,
Bedford Park
South Australia 5042
Ethics committee country [1] 301183 0
Australia
Date submitted for ethics approval [1] 301183 0
09/03/2018
Approval date [1] 301183 0
30/05/2018
Ethics approval number [1] 301183 0
422.13

Summary
Brief summary
This study aims to evaluate the effectiveness of the 'Faecal Immunochemical Test' (FIT) as a diagnostic tool in patients considered at elevated risk for colorectal cancer and who have an upcoming surveillance colonoscopy.

Who is it for?
You may be eligible to join this study if you are male or female, aged 18 years or older, are enrolled in the SCOOP Program and have a scheduled surveillance colonoscopy.

Study details
All patients enrolled in the SCOOP program, with a pending surveillance colonoscopy will be invited to complete and return a FIT kit, two weeks prior to their colonoscopy so the results from the FIT and the colonoscopy, can be compared to each other to validate the FIT as an effective surveillance tool.

The purpose of this study is to understand the accuracy of FIT relative to colonoscopy with regard to detecting both colorectal cancer and polyps that are pre-cancerous. While much is known about the effectiveness of FIT as a general screening tool, we would like to gather data on its effectiveness when compared to colonoscopy, in a population of people who are under surveillance with colonoscopy.

Our research may lead to increased confidence and validation in the use of FIT as an effective surveillance tool for patients with an elevated risk for colorectal cancer and reduce the need for unnecessary colonoscopies for patients within the SCOOP Program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86134 0
Dr Erin Symonds
Address 86134 0
Bowel Health Service
Flinders Centre for Innovation in Cancer
Level 3
Bedford Park
South Australia 5042
Country 86134 0
Australia
Phone 86134 0
+61 8 8404 2813
Fax 86134 0
Email 86134 0
Erin.Symonds@sa.gov.au
Contact person for public queries
Name 86135 0
Ms Kathryn Cornthwaite
Address 86135 0
Bowel Health Service
Flinders Centre for Innovation in Cancer
Level 2
Bedford Park
South Australia 5042
Country 86135 0
Australia
Phone 86135 0
+61 8 8204 5534
Fax 86135 0
Email 86135 0
Kathryn.Cornthwaite@sa.gov.au
Contact person for scientific queries
Name 86136 0
Dr Erin Symonds
Address 86136 0
Bowel Health Service
Flinders Centre for Innovation in Cancer
Level 3
Bedford Park
South Australia 5042
Country 86136 0
Australia
Phone 86136 0
+61 8 8404 2813
Fax 86136 0
Email 86136 0
Erin.Symonds@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Individual data / or any raw data will be shared without appropriate future consent and/or ethical approval.
What supporting documents are/will be available?
Clinical study report
Summary results
Not applicable