Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000538943
Ethics application status
Approved
Date submitted
19/05/2011
Date registered
25/05/2011
Date last updated
26/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Colorectal cancer screening and early detection in people with Chronic Kidney Disease
Scientific title
A diagnostic test accuracy study for colorectal cancer screening using immunochemical faecal occult blood testing in a chronic kidney disease population
Secondary ID [1] 260086 0
Nil
Universal Trial Number (UTN)
U1111-1121-1269
Trial acronym
DETECT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 265886 0
Chronic Kidney Disease 267943 0
Condition category
Condition code
Renal and Urogenital 265907 265907 0 0
Kidney disease
Cancer 265908 265908 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All eligible participants will receive an imunochemical faecal occult blood test (IFOBT) kit (EIKEN brand) containing the test and instructions, with additional explanation provided by study staff, as required. A sample is then collected from two separate bowel motions. All samples will be self-collected.

All completed kits will be sent and processed in a designated central laboratory and analysed according to the company’s standardised specifications. The results of this test can be positive, negative or inconclusive. All results will be sent via mail to the corresponding treating physicians, the participants and the research assistants at the Centre for Kidney Research. The screen is considered positive when one of the samples contains at least 50ng/ml of haemoglobin. Negative results are not followed up in the study but these patients are advised to continue with annual screening with their health practitioner. If the results are inconclusive, the participants will be contacted by phone and asked to repeat the test.

Only participants with positive IFOBT findings will be referred for a diagnostic colonoscopy at a designated colonoscopic service. Study staff will track participants with positive IFOBT results and will ensure the referral process is scheduled effectively and efficiently for a colonoscopy. The participants will not be required to pay for the IFOBT kit or the diagnostic colonoscopy. Other clinical significant pathologies such as polyps, adenomas, vascular lesions will be documented and recorded. Wherever possible, they will be resected and sent for pathology. Depending upon the stage of initial diagnosis, further treatment may be required for participants with malignant polyps and cancers. All cancer diagnoses, including stage, histological types, treatment effect, will be reported to the National Bowel Screening Program Register, the Central Cancer Registry of New South Wales (located within the Cancer Institute of NSW) and the Australian and New Zealand Dialysis and Transplant Registry (ANZDATA). Study staff will ensure the treatment plans and follow-up are taking place efficiently and effectively.
Intervention code [1] 264603 0
Early detection / Screening
Intervention code [2] 266644 0
Diagnosis / Prognosis
Comparator / control treatment
The reference standard should ideally be performed in all patients regardless of the screen test results and health status to avoid verification bias, but it would be medically and ethically unjustified to subject all patients (with and without positive screens) to receive the diagnostic colonoscopic procedure. Instead, all participants with positive screens, with or without a cancer, will be followed up clinically, with a phone-call for up to a period of 4 years. All negative FOBT screens will also be followed up clinically with a phone call, at the end of 2 and 4 years. For validation of such a procedure, we will also compare results of patients who had diagnostic colonoscopies and the standard diagnoses based upon clinical follow-up. To ensure adequate follow-up and accurate calculation of diagnostic test accuracies, we will compare our cancer records with that of the Central Cancer Registry of N.S.W. and the ANZDATA Registry. The ANZDATA Registry contains one of the largest and the most comprehensive databases of patients with renal replacement therapy in the world. The ANZDATA Registry collects all cancer records (stage, histological types and treatment) except for squamous and basal cell carcinomas of the skin.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266783 0
Prevalence of a positive screening result (defined as positive IFOBT with at least one of the two stool samples containing at least 50ng/ml of haemoglobin) in people with chronic kidney disease in stages 3-5, dialysis and kidney transplant populations using the immunochemical faecal occult blood test.
Timepoint [1] 266783 0
Five years
Primary outcome [2] 266784 0
Prevalence of colorectal cancer as determined with diagnostic colonoscopy, in people with chronic kidney disease in stages 3-5, dialysis and kidney transplant populations.
Timepoint [2] 266784 0
Five years
Primary outcome [3] 266785 0
Test performance characteristics of immunochemical faecal occult blood screening, including: test specificity, positive predictive values and negative predictive value for colorectal cancers.
Timepoint [3] 266785 0
Five years
Secondary outcome [1] 276385 0
Stage distribution and disease progression of screened detected colorectal cancers as determined by diagnostic colonoscopy. To ensure adequate follow-up and accurate calculation of diagnostic test accuracies, we will compare our cancer records with that of the Central Cancer Registry of N.S.W. and the ANZDATA Registry.
Timepoint [1] 276385 0
Five years
Secondary outcome [2] 276386 0
Stage distribution and disease progression of interval cancers as determined by diagnostic colonoscopy. To ensure adequate follow-up and accurate calculation of diagnostic test accuracies, we will compare our cancer records with that of the Central Cancer Registry of N.S.W. and the ANZDATA Registry.
Timepoint [2] 276386 0
Five years
Secondary outcome [3] 276387 0
Adverse outcomes from screening, diagnosis, and treatment of colorectal cancers, including bleeding, infection, perforations and anxiety related to positive test results. Clinical assessment and management of these will include blood tests and CT scans.
Timepoint [3] 276387 0
Five years

Eligibility
Key inclusion criteria
* Australian citizens or permanent residents who are holders of Medicare cards and/or DVA gold cards
* Aged 35 – 74
* People with chronic kidney disease in stages 3 – 5 (defined as estimated glomerular filtration rate (eGFR) of less than 60ml/min/1.73m^2)
* People with kidney alone or kidney and pancreas transplants
* People on dialysis
* Average risk for colorectal cancer (Average risk is defined as no personal history of colorectal cancer or adenomatous polyps, no family history of colorectal cancer in a first-degree relative and no history of inflammatory bowel disease)
Minimum age
35 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active gastrointestinal bleeding
* Previous gastrointestinal bleeding
* Previous colonoscopies in the past 2 years
* Current pregnancy
* A personal history of colorectal cancer or adenomatous polyps, a family history of colorectal cancer in a first-degree relative and a history of inflammatory bowel disease.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with chronic kidney disease in stages 3-5, dialysis or transplant populations will be recruited from the Sydney West Area Health Service. All eligible patients from each of these area health services will be identified and the researchers will consent the patients, if necessary, with a health care interpreter. All eligible participants will receive an IFOBT kit containing the test and instructions, with additional explanation provided by study staff, as required. All participants with positive IFOBT findings will be referred to a diagnostic colonoscopy at a designated colonoscopic service. Study staff will track participants with positive IFOBT results and will ensure the referral process is scheduled effectively and efficiently with no more than four weeks waiting time for a colonoscopy.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/05/2010
Actual
28/05/2010
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
29/11/2019
Actual
14/12/2015
Sample size
Target
1700
Accrual to date
Final
1707
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment postcode(s) [1] 4023 0
2050
Recruitment postcode(s) [2] 4022 0
2065
Recruitment postcode(s) [3] 13318 0
2138 - Concord West
Recruitment postcode(s) [4] 4017 0
2145
Recruitment postcode(s) [5] 4020 0
2148
Recruitment postcode(s) [6] 13320 0
2153 - Bella Vista
Recruitment postcode(s) [7] 13319 0
2250 - Gosford
Recruitment postcode(s) [8] 4018 0
2747
Recruitment postcode(s) [9] 4021 0
2800
Recruitment postcode(s) [10] 13321 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 7932 0
Spain
State/province [1] 7932 0
Barcelona
Country [2] 7933 0
Canada
State/province [2] 7933 0
Toronto
Country [3] 7934 0
New Zealand
State/province [3] 7934 0
Christchurch

Funding & Sponsors
Funding source category [1] 267104 0
Government body
Name [1] 267104 0
National Health and Medical Research Council - Screening and Test Evaluation Program (STEP) grant (691626)
Country [1] 267104 0
Australia
Primary sponsor type
Individual
Name
Dr Germaine Wong
Address
Renal Medicine A6C
Westmead Hospital
Hawkesbury Rd & Darcy Road
Westmead NSW 2145
Australia
Country
Australia
Secondary sponsor category [1] 264186 0
Individual
Name [1] 264186 0
Professor Jeremy Chapman
Address [1] 264186 0
Director of Acute Interventional Service
Department of Renal Medicine
Westmead Hospital
Cn Hawkesbury and Darcy Roads
Westmead NSW 2145
Australia
Country [1] 264186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267084 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 267084 0
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Ethics committee country [1] 267084 0
Australia
Date submitted for ethics approval [1] 267084 0
23/02/2010
Approval date [1] 267084 0
25/03/2010
Ethics approval number [1] 267084 0
HREC2010/2/4.5(3101)AU RED HREC/10/WMEAD/13
Ethics committee name [2] 297871 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [2] 297871 0
Level 9, 8 Central Avenue, Australian Technology Park, Eveleigh NSW 2015
PO Box 41, Alexandria, NSW 1435
Ethics committee country [2] 297871 0
Australia
Date submitted for ethics approval [2] 297871 0
Approval date [2] 297871 0
23/05/2013
Ethics approval number [2] 297871 0
HREC/13/CIPHS/13

Summary
Brief summary
This study aims to assess the health benefits, harms, and costs of early detection for colorectal cancer in people with chronic kidney disease.

Who is it for?
You can join this study if you are aged 35-74 years and have chronic kidney disease in stages 3-5, have had a kidney transplant, or are on dialysis. You must be an Australian citizen or permanent resident who holds a Medicare and/or DVA gold card. You should have no personal or family history of colorectal cancer, no previous or current gastro-intestinal bleeding, no inflammatory bowel disease, and have not had a colonoscopy within the last two years.

Trial details
In this study, all participants will receive a home testing kit, called the immunochemical faecal occult blood test (IFOBT) kit. This will contain instructions, and additional explanation will be provided by study staff as required. The test will require participants to collect a sample from two of their separate bowel motions. The completed test kits will then be sent and processed in a laboratory to determine whether the result is negative, positive, or inconclusive. Participants with positive findings will be referred for a diagnostic colonoscopy. All diagnoses are recorded and communicated to participants. All participants will be followed up for a period of four years.
Trial website
www.kidney-research.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32553 0
A/Prof Germaine Wong
Address 32553 0
Renal Medicine A6C
Westmead Hospital
Hawkesbury Rd & Darcy Road
Westmead NSW 2145
Australia
Country 32553 0
Australia
Phone 32553 0
+6129845 0118
Fax 32553 0
Email 32553 0
germaine.wong@health.nsw.gov.au
Contact person for public queries
Name 15800 0
A/Prof Dr Germaine Wong
Address 15800 0
Renal Medicine A6C
Westmead Hospital
Hawkesbury Rd & Darcy Road
Westmead NSW 2145
Australia
Country 15800 0
Australia
Phone 15800 0
+6129845 0118
Fax 15800 0
Email 15800 0
germaine.wong@health.nsw.gov.au
Contact person for scientific queries
Name 6728 0
A/Prof Dr Germaine Wong
Address 6728 0
Renal Medicine A6C
Westmead Hospital
Hawkesbury Rd & Darcy Road
Westmead NSW 2145
Australia
Country 6728 0
Australia
Phone 6728 0
+6129845 0118
Fax 6728 0
Email 6728 0
germaine.wong@health.nsw.gov.au

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.