Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000227594
Ethics application status
Approved
Date submitted
1/06/2006
Date registered
5/06/2006
Date last updated
5/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of simplified stool sampling on participation in colon cancer screening
Scientific title
Rate of participation in faecal immunochemical test-based colorectal cancer screening: The impact of one-stool versus two-stool sampling
Secondary ID [1] 264 0
Bowel Health Service, Repatriation General Hospital (RGH): 2006-902
Secondary ID [2] 265 0
Repatriation General Hospital (RGH) Human Research Ethics Committee (HREC): 08/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 1205 0
Condition category
Condition code
Cancer 1290 1290 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation at 12 weeks from offer of screening for colorectal cancer in the intervention group using a screening test requiring only a single stool sample to be collected for testing for occult blood.
Intervention code [1] 1084 0
Early detection / Screening
Comparator / control treatment
Participation at 12 weeks from offer in a control group using the same test in standard mode where two stool samples are collected from consecutive bowel motions.
Control group
Active

Outcomes
Primary outcome [1] 1756 0
Participation (yes or no)
Timepoint [1] 1756 0
At 12 weeks from postal offer of colorectal cancer screening
Secondary outcome [1] 3105 0
Population participation
Timepoint [1] 3105 0
At 2 weeks from offer
Secondary outcome [2] 3106 0
Population participation
Timepoint [2] 3106 0
At 6 weeks
Secondary outcome [3] 3107 0
Test positivity rates
Timepoint [3] 3107 0
At 12 weeks from offer,
Secondary outcome [4] 3108 0
Yield of neoplasia
Timepoint [4] 3108 0
From all tests positive 12 weeks from offer of screening.

Eligibility
Key inclusion criteria
Residing in specific postcodes in southern Adelaide.
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Specified pre-existing clinical conditions that makes FOBT-screening uninformative or that preclude follow-up colonoscopy, people already participating in other Bowel Health Service research studies.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects obtained fron Australian electoral roll, allocated to group by central adminisration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1416 0
Commercial sector/Industry
Name [1] 1416 0
Enterix Inc
Country [1] 1416 0
United States of America
Primary sponsor type
Individual
Name
Prof Graeme Young, Dept of Medicine, Flinders University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 1242 0
Individual
Name [1] 1242 0
Mr Stephen Cole, Bowel Health Service, Repartiation General Hospital Daw Park
Address [1] 1242 0
Country [1] 1242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2772 0
Repatriation General Hospital Daw Park
Ethics committee address [1] 2772 0
Daws Road Daw Park SA 5041
Ethics committee country [1] 2772 0
Australia
Date submitted for ethics approval [1] 2772 0
Approval date [1] 2772 0
Ethics approval number [1] 2772 0
08/06

Summary
Brief summary
There has been limited uptake of population screening for colorectal cancer in Australia and other western countries, using faecal occult blood testing. We have previously determined that the InSure faecal immunochemical test (FIT) used in single sample format has similar sensitivity for significant colorectal neoplasia (cancer and significant adenomas) relative to the standard two stool sample test. Our hypothesis is that single stool sampling will result in improved population participation in screening compared to the standard InSure test. This study will compare population participation in screening in two groups, one offered the screening test in single stool sample format, compared to the control (standard InSure test, 2 stool sample format).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35997 0
Address 35997 0
Country 35997 0
Phone 35997 0
Fax 35997 0
Email 35997 0
Contact person for public queries
Name 10273 0
Mr Stephen Cole
Address 10273 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Road
Daw Park SA 5041
Country 10273 0
Australia
Phone 10273 0
+61 8 82751838
Fax 10273 0
+61 8 82751083
Email 10273 0
[email protected]
Contact person for scientific queries
Name 1201 0
Mr Stephen Cole
Address 1201 0
Repatriation General Hospital Daw Park
Daws Road
Daw Park SA 5041
Country 1201 0
Australia
Phone 1201 0
+61 8 82751838
Fax 1201 0
+61 8 82751083
Email 1201 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.