Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000457044
Ethics application status
Approved
Date submitted
27/05/2010
Date registered
4/06/2010
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of the accuracy of two bowel cancer test kits in healthy people.
Scientific title
An open study to evaluate QuickVue (Registered Trademark (R)) FIT(R), a new occult blood test for the detection of colorectal neoplasia: Comparison of specificity with Hemoccult II(R) Sensa(R) in healthy volunteers.
Secondary ID [1] 251766 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer 257361 0
Condition category
Condition code
Cancer 257507 257507 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is an open study designed to determine the clinical specificity of the bowel cancer screening tests QuickVue(R) faecal immunochemical test (FIT) and to compare this to Hemoccult II(R) Sensa(R).
A new immunochemical, faecal occult blood test (FOBT) QuickVue(R)FIT has recently been developed, that incorporates features that may result in improved population participation.
These features relate to sampling process itself where a specimen is taken by inserting into the stool a small grooved probe instead of the more traditional spatula sampling; therefore the QuickVue(R) FIT device uses a stool sampling procedure where a small probe is inserted into the stool surface at multiple points and then transferred to a plastic container containing a stabilization solution which is then sealed. The test is then activated and a stable test result is generated which is concealed from the participant.

The Hemoccult II(R) Sensa(R) device is a guaiac (chemical) test, which employs a direct stick-based faecal sampling method to collect a sample from a stool captured by defaecating onto a stool collection sheet held above toilet bowel water. The faecal sample is then smeared onto a collection card by the patient using a small wooden spatula, allowed to dry and sent to the developing laboratory using postal system approved packaging.

Therefore one significant difference between these devices is that the Hemoccult II(R) Sensa(R) uses a stick-based stool sampling method while the QuickVue(R) FIT uses a probe sampling method. While there are other inherent differences between the sampling methodologies used in the QuickVue(R) FIT and the Hemoccult II(R) Sensa(R) test devices, a study based on a direct, per-stool comparison is practical.

To complete both devices a total period of approximately 6 days, depending on bowel habit, is expected.

This study commenced enrolment 7 July 2009. Enrolment is expected to be completed in June/July 2010.

These tests are undertaken simultaneously using the same stool sample; i.e. the participant will use both the FOBT QuickVue(R) FIT and the Hemoccult II(R) Sensa(R) device on the same sample of stool on three different occasions.
All participants use the Hemoccult II(R) Sensa(R) device first followed by the QuickVue(R) FIT
This is a single procedure. Participants only receive the tests on one occasion.
Intervention code [1] 256452 0
Not applicable
Comparator / control treatment
The Hemoccult II(R) Sensa(R) device, a guaiac (chemical) test.
Hemoccult II(R) Sensa(R) is a development of Hemoccult II(R), which was the Faecal Occult Blood Test (FOBT) used in the randomised controlled trials that showed that screening reduced mortality from Colorectal Cancer (CRC).
Control group
Active

Outcomes
Primary outcome [1] 258421 0
The primary aim of this study is to compare the clinical specificity (proportion of positive tests in a population known not to have the condition under test) of the faecal immunochemical test (FIT) QuickVue"Registered Trade Mark (R)"
relative to an approved chemical device Hemoccult II(R) Sensa(R)
The device end point and result for each patient will be defined as per the device manufacture?s instructions. In the case of the Hemoccult II(R) Sensa(R) device, a positive result recorded for one or more of the six individual samples, corresponding to three separate bowel movements, will yield a positive result for that patient. In the case of the QuickVue(R) FIT test, the positivity or negativity for that patient will be interpreted in similar fashion.
Timepoint [1] 258421 0
Specificity is assessed at completion of both tests
Secondary outcome [1] 264195 0
To compare the clinical specificity of QuickVue(R) FIT using test devices with differing sensitivities i.e. cut-offs set at 50and 100 ngHb/ml).
Timepoint [1] 264195 0
Specificity is assessed at completion of both tests
Secondary outcome [2] 264196 0
To compare the clinical specificity of each test on a one, two or three stool basis.
Timepoint [2] 264196 0
Specificity is assessed at completion of both tests

Eligibility
Key inclusion criteria
1) Having had a complete colonoscopy judged to be an adequate examination by the endoscopist in the 18 months prior to the likely date of the study FOBT result.
2) With a diagnosis of a normal colon/rectum at previous colonoscopy (i.e. no diagnosis of any colorectal neoplastic or non-neoplastic pathologies likely to cause colonic bleeding).
3) Able to give informed written consent
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Unable to follow study protocol instructions
2) Presence of overt rectal bleeding in last 4 weeks
3) Females who are actively or within three (3) days of menstruating or passing blood per vagina (PV) at any time during the collection period
4) Biopsy of the colon or rectum within prior seven (7) days of collecting faecal samples.
5) Known or suspected to be unable to comply with the study protocol as judged by the investigator (eg. unable or unwilling to stop taking non-steroidal anti-inflammatory drugs (NSAIDs eg ibuprofen, naproxen or aspirin) or to exclude high peroxidise foods).
6) Haematuria at time of collection or any other bodily bleeding that could contaminate the specimen.
7)Subsequent ascertainment that pathology was actually present at the colonoscopy considered to be normal.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2009
Actual
15/07/2009
Date of last participant enrolment
Anticipated
Actual
7/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256964 0
Commercial sector/Industry
Name [1] 256964 0
Quidel Corporation
Country [1] 256964 0
United States of America
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
1 Flinders Drive
Bedford Park
5042
South Australia
Country
Australia
Secondary sponsor category [1] 256227 0
Hospital
Name [1] 256227 0
Repatriation General Hospital
Address [1] 256227 0
Daws Road
Daw Park
5041
South Australia
Country [1] 256227 0
Australia
Other collaborator category [1] 1253 0
Commercial sector/Industry
Name [1] 1253 0
Quidel Corporation
Address [1] 1253 0
10165 McKellar Court San Diego, CA 92121
Country [1] 1253 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258982 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 258982 0
1 Flinders Drive
Bedford Park
5042 South Australia
Ethics committee country [1] 258982 0
Australia
Date submitted for ethics approval [1] 258982 0
Approval date [1] 258982 0
03/08/2007
Ethics approval number [1] 258982 0
Research Application Number 17/07

Summary
Brief summary
A study comparing two different faecal occult blood testing kits (FOBT). These are tests for detecting early signs of bowel cancer.
Patients will be invited who have had a diagnosis of a normal bowel after colonoscopy within the last eighteen months
The aim of this study is to determine the accuracy of a new FOBT kit (QuickVue(R) FIT(R)) compared to a proven FOBT kit (Hemoccult II(R) Sensa(R) for detecting the presence of hidden blood in the stool (occult blood). Occult blood in stool is an indication of a number of relatively mild bowel diseases as well a symptom of bowel cancer and bowel polyps. We need to be sure that the QuickVue test does not detect extremely low levels of blood loss which occurs in normal healthy people, to ensure that the test does not give false positive results.
Trial website
Trial related presentations / publications
there are no publications
Public notes

Contacts
Principal investigator
Name 31145 0
Prof Graeme Young
Address 31145 0
FCIC L3:100
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 31145 0
Australia
Phone 31145 0
+61 417 860 540
Fax 31145 0
Email 31145 0
[email protected]
Contact person for public queries
Name 14392 0
Ms Jane Upton
Address 14392 0
Department of Gastroenterology
1 Flinders Drive
Flinders Medical Centre
Bedford Park
South Australia 5042
Country 14392 0
Australia
Phone 14392 0
61 8 82046071
Fax 14392 0
Email 14392 0
[email protected]
Contact person for scientific queries
Name 5320 0
Mr Mr Steve Cole
Address 5320 0
Bowel Health Service
Repatriation General Hospital
216 Daws Road
Daw Park
5041 South Australia
Country 5320 0
Australia
Phone 5320 0
61 8 82751838
Fax 5320 0
Email 5320 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

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