Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000459426
Ethics application status
Approved
Date submitted
28/08/2007
Date registered
11/09/2007
Date last updated
27/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The value of interval faecal occult blood testing in colonoscopic screening programs for those at above average risk for colorectal cancer.
Scientific title
The value of interval faecal occult blood testing in colonoscopic screening programs for those at above average risk for colorectal cancer.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer. 2307 0
Condition category
Condition code
Cancer 2404 2404 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ongoing annual offer of faecal occult blood test screening in years when colonoscopy not scheduled, within a colonoscopy based surveillance program. At present the duration would be ongoing till the invitee reaches 75 years, then subject to invitee's wishes and health status.
Intervention code [1] 2067 0
Early detection / Screening
Comparator / control treatment
Absence of faecal occult blood test screening.
Control group
Active

Outcomes
Primary outcome [1] 3351 0
Program yield of neoplasia.
Timepoint [1] 3351 0
7 years from initiation of program.
Secondary outcome [1] 5568 0
Program stage of lesion.
Timepoint [1] 5568 0
7 years from initiation of program

Eligibility
Key inclusion criteria
Registered on colonoscopy surveillance database, having undergone at least 2 adequate colonoscopies greater than 1 year apart,
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Full pathology details not available for lesions detected.

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)
The treatment/intervention is self-allocated ie invitees choose whether to participate in the intervention or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 262 0
all SA plus some NSW (Broken Hill), so too many to specify

Funding & Sponsors
Funding source category [1] 2562 0
Charities/Societies/Foundations
Name [1] 2562 0
Foundation Daw Park
Country [1] 2562 0
Australia
Funding source category [2] 2563 0
Commercial sector/Industry
Name [2] 2563 0
Enterix Australia
Country [2] 2563 0
Australia
Funding source category [3] 2564 0
Hospital
Name [3] 2564 0
Repatriation General Hospital
Country [3] 2564 0
Australia
Funding source category [4] 2566 0
University
Name [4] 2566 0
Flinders University
Country [4] 2566 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 2322 0
Hospital
Name [1] 2322 0
Repatriation General Hospital
Address [1] 2322 0
Daws Rd
Daw Park SA 5041
Country [1] 2322 0
Australia
Secondary sponsor category [2] 2354 0
Hospital
Name [2] 2354 0
Flinders Medical Centre
Address [2] 2354 0
Bedford Park SA
Country [2] 2354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4523 0
Research and Ethics Committee
Ethics committee address [1] 4523 0
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Ethics committee country [1] 4523 0
Australia
Date submitted for ethics approval [1] 4523 0
Approval date [1] 4523 0
01/11/2001
Ethics approval number [1] 4523 0
55/01

Summary
Brief summary
This study examines the value of interval faecal occult blood test within a colonoscopy-based surveillance program for those at moderately increased risk for developing colorectal cancer.

Who is it for?
You may be eligible for this study if you are considered to be at moderate risk for colorectal cancer development based on a personal history of colonic adenomas or colorectal cancer or have a verified family history. You also need to be currently registered with one of the Southern Adelaide regional public hospital colorectal cancer prevention programs.

Trial details.
A faecal occult blood test is a test that can detect tiny traces of blood in the stool which cannot be seen with the naked eye. ‘Occult’ literally means hidden or unknown. A positive faecal occult blood test should be followed by a colonoscopy where colorectal cancer or significant large polyps may be diagnosed at a relatively early stage when there are no obvious symptoms.

At present, participants registered with the colonoscopy surveillance program in Southern Adelaide region have scheduled colonoscopies in accordance with the National Health and Medical Research Council’s clinical practice guidelines (2005), at a frequency depending on risk level. Eligible registrants will be offered a faecal occult blood test (interval test) in each of the years between scheduled colonoscopies. The study compares the yield of colorectal cancers and adenomas detected at colonoscopies between participants who do have interval faecal occult blood tests and those who choose not to participate.
Trial website
Trial related presentations / publications
Bampton PA, Sandford JJ, Cole SR, Smith A, Morcom J, Cadd B, Young GP. Interval faecal occult blood testing in a colonoscopy based screening program detects additional pathology. Gut 2005; 54: 803-6.
Public notes

Contacts
Principal investigator
Name 28014 0
Address 28014 0
Country 28014 0
Phone 28014 0
Fax 28014 0
Email 28014 0
Contact person for public queries
Name 11171 0
Stephen Cole
Address 11171 0
Bowel Health Service
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 11171 0
Australia
Phone 11171 0
+61 8 82751838
Fax 11171 0
Email 11171 0
[email protected]
Contact person for scientific queries
Name 2099 0
Stephen Cole
Address 2099 0
Bowel Health Service
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 2099 0
Australia
Phone 2099 0
+61 8 82751838
Fax 2099 0
Email 2099 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.