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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000462684 |
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Date of registration:
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22/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The influence of initial screening test technology on participation in rescreening for colorectal cancer
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Scientific title:
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The influence of initial screening test technology on participation in rescreening for colorectal cancer |
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Date of first enrolment:
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02/04/2001 |
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Target sample size:
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1818 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12605000462684.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Contacts
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Name:
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Mr Stephen Cole
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Address:
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Bowel Health Service
Repatriation General Hospital Daw Park
Daws Road
Daw Park SA 5041
Australia |
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Telephone:
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+61 8 82751838 |
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Email:
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scoles@rgh.sa.gov.au |
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Affiliation:
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Name:
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Ms Alicia Smith
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Address:
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Bowel Health Service
Repatriation General Hospital Daw Park
Daws Rd
Daw Park SA 5041
Australia |
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Telephone:
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+61 8 82751075 |
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Email:
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alicia.smith@rgh.sa.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: First round of screeningInclusion: Present on the electoral roll of the South Australian Electoral Commission on 01/02/2001.
Exclusion criteria: None but invitees provided with a list of conditions and settings where faecal occult blood based screening is inappropriate and requesting self-exclusion by not participating.Second round of screening.Inclusion: Selected for the first round of screening invitationsExclusion: People identified during Round 1 as having gastrointestinal conditions that invalidate screening results, people identified with mental and physical disabilities that prevent them from following the study protocol, people known to have had a neoplasia negative colonoscopy 5 years prior to a screening offer, people whose first round kits were returned unopened and 'not known at this address', people who informed the screening facility that they did not want further contact.
Age minimum:
50 Years
Age maximum:
69 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Screening for bowel cancer;
Screening for bowel cancer
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Cancer - Bowel - Back passage (rectum) or large bowel (colon)
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Intervention(s)
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The aim is to determine the effect of the type of test offered in a first round of a screening program for colorectal cancer on participation in a second round.
Group 1: First round of screening Hemoccult II Sensa, low technology test. Second round of screening: InSure test, high technology.
Group 2: First round of screening: FlexSure OBT, mid technology test. Second round: InSure OBT, high technology.
Group 3: First round of screening: InSure OBT, high technology test. Second round: InSure OBT, high technology.
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Primary Outcome(s)
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Paricipation in screening defined as return of a screening kit 12 weeks from offer.[]
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Secondary Outcome(s)
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Test positivity rate[]
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Yield of neoplasia[]
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Source(s) of Monetary Support
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Bushel Fund
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Ethics review
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Status: Not approved
Approval date:
Contact:
Repatriation General Hospital Daw Park
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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