ANZCTR - Registration

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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

16/06/2024

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Public Health

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]

Early Detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Faecal haemoglobin level as assessed by FIT test.

Timepoint [1]

assessed within 1 - 2 weeks before the colonoscopy

Secondary outcome [1]

Severity of colonic lesions as assessed by colonoscopy.

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients who have advised SCOOP that they 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

1/09/2018

Actual

3/09/2018

Date of last participant enrolment

Anticipated

30/11/2025

Actual

Date of last data collection

Anticipated

31/12/2025

Actual

Sample size

Target

3500

Accrual to date

1560

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

Noarlunga Health Service - Noarlunga Centre

Recruitment hospital [3]

Flinders Private Hospital - Bedford Park

Recruitment hospital [4]

Tennyson Centre Day Hospital - Kurralta Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5168 - Noarlunga Centre

Recruitment postcode(s) [3]

5037 - Kurralta Park

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Flinders University of South Australia

Address [1]

Flinders Centre for Innovation in Cancer
Bedford Park,
South Australia 5042

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

SALHN Office for Research
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive,
Bedford Park
South Australia  5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/03/2018

Approval date [1]

30/05/2018

Ethics approval number [1]

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

A/Prof Erin Symonds

Address

Bowel Health Service
Flinders Centre for Innovation in Cancer
Level 3
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 8 8404 2813

Fax

Erin.Symonds@sa.gov.au

Contact person for public queries

Name

Kathryn Cornthwaite

Address

Bowel Health Service
Flinders Centre for Innovation in Cancer
Level 2
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 8 8204 5534

Fax

Kathryn.Cornthwaite@sa.gov.au

Contact person for scientific queries

Name

Erin Symonds

Address

Bowel Health Service
Flinders Centre for Innovation in Cancer
Level 3
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 8 8404 2813

Fax

Erin.Symonds@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6316	Informed consent form					375769-(Uploaded-12-12-2019-12-32-48)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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