Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000154303
Ethics application status
Approved
Date submitted
6/03/2008
Date registered
2/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening for Colorectal Cancer in Recipients of Kidney Transplants
Scientific title
Screening for Colorectal Cancer with Faecal Occult Blood Testing and Colonoscopy in Kidney Transplant recipients: a prospective cross-sectional study.
Secondary ID [1] 262792 0
Screnning for Colorectal Cancer in Recipients of Kidney Transplants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation - post transplant malignancy 2909 0
Colorectal Cancer 2910 0
Condition category
Condition code
Cancer 3044 3044 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
1. Faecal occult blood testing (FOBT). Participants will perform FOBT following enrolment. This involves using a patient kit to sample their own stools for the presence of blood, mailing their testing kit in to a central lab once it is completed. Testing will be conducted once but may involve sampling several stools.
2. Colonoscopy. All participants will also undergo colonoscopy following the completion of FOBT, regardless of the result. This will be performed within a target of 3 months post enrolment.
Intervention code [1] 2638 0
Early detection / Screening
Comparator / control treatment
General population offered Colorectal cancer screening with faecal occult blood testing (followed up by colonoscopy if positive).
Control group
Historical

Outcomes
Primary outcome [1] 3926 0
Sensitivity and specificity of faecal occult blood testing for colorectal cancer and colorectal neoplasia, using colonscopy as the "gold standard" procedure.
Timepoint [1] 3926 0
One-off screening with both FOBT and colonoscopy, with a completion target of 3 months post enrolment.
Secondary outcome [1] 6605 0
Rate of Colorectal Cancer and colorectal neoplasia found at screening colonoscopy.
Timepoint [1] 6605 0
One-off screening colonoscopy, with a completion target of 3 months post enrolment.

Eligibility
Key inclusion criteria
- Kidney transplant recipients in South Australia >=50 years old, more than 6 months post transplant
- Willing and able to give informed consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active unstable cardiopulmonary disease
- Terminal illness, life threatening malignancy
- Bleeding disorders or unable to stop oral anti-coagulants for colonoscopy
- Colonoscopy within 12 months prior to enrolment
- Failed kidney transplant and return to dialysis prior to enrolment
- Symptoms or signs suggestive of colorectal cancer
- Previous personal history of colorectal cancer, advanced adenoma or chronic ulcerative colitis
- Family history of Familial Adenomatous Polyposis (FAP) or Hereditary non-polyposis colorectal cancer (HNPCC)

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
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 625 0
5011
Recruitment postcode(s) [2] 626 0
5000
Recruitment postcode(s) [3] 805 0
5042
Recruitment postcode(s) [4] 806 0
5041

Funding & Sponsors
Funding source category [1] 3158 0
Hospital
Name [1] 3158 0
Queen Elizabeth Hospital
Country [1] 3158 0
Australia
Funding source category [2] 3159 0
Hospital
Name [2] 3159 0
Flinders Medical Centre
Country [2] 3159 0
Australia
Funding source category [3] 3160 0
Hospital
Name [3] 3160 0
Repatriation General Hospital
Country [3] 3160 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Collins
Address
Central Northern Adelaide Renal and Transplantation Service,
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 2833 0
Individual
Name [1] 2833 0
Associate Professor Toby Coates
Address [1] 2833 0
Central Northern Adelaide Renal and Transplantation Service,
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [1] 2833 0
Australia
Secondary sponsor category [2] 2834 0
Individual
Name [2] 2834 0
Associate Professor Stephen McDonald
Address [2] 2834 0
Central Northern Adelaide Renal and Transplantation Service,
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [2] 2834 0
Australia
Other collaborator category [1] 223 0
Individual
Name [1] 223 0
Professor Graeme Russ
Address [1] 223 0
Central Northern Adelaide Renal and Transplantation Service,
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [1] 223 0
Australia
Other collaborator category [2] 224 0
Individual
Name [2] 224 0
Professor Graeme Young
Address [2] 224 0
Department of Gastroenterology and Hepatology and Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Bedford Park South Australia 5042
Country [2] 224 0
Australia
Other collaborator category [3] 225 0
Individual
Name [3] 225 0
Associate Professor Peter Bampton
Address [3] 225 0
Department of Gastroenterology and Hepatology Flinders Medical Centre
Bedford Park South Australia 5042
Country [3] 225 0
Australia
Other collaborator category [4] 226 0
Individual
Name [4] 226 0
Mr Steve Cole
Address [4] 226 0
Bowel Health Service and Department of Medicine
Flinders University of South Australia
Repatriation General Hospital
Daws Road
Daws Park South Australia 5041
Country [4] 226 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5226 0
Central Northern Adelaide Health Service Ethics of Human Research Committee
Ethics committee address [1] 5226 0
Research Secretariat
Ground Floor, Basil Hetzel Institute
Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 5226 0
Australia
Date submitted for ethics approval [1] 5226 0
Approval date [1] 5226 0
17/03/2008
Ethics approval number [1] 5226 0
2008043
Ethics committee name [2] 5551 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 5551 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [2] 5551 0
Australia
Date submitted for ethics approval [2] 5551 0
Approval date [2] 5551 0
15/05/2008
Ethics approval number [2] 5551 0
080510
Ethics committee name [3] 5552 0
Flinders Clinical Research Ethics Committee
Ethics committee address [3] 5552 0
Flinders Medical Centre
Bedford Park, SA 5042
Ethics committee country [3] 5552 0
Australia
Date submitted for ethics approval [3] 5552 0
Approval date [3] 5552 0
24/06/2008
Ethics approval number [3] 5552 0
118/08

Summary
Brief summary
The risk of cancer, including colorectal cancer is increased in recipients of kidney transplants. This study is designed to evaluate the standard population screening tools for colorectal cancer, ie faecal occult blood testing and colonoscopy, in this high risk population. All recruited patients will undergo both of these screening tests, and from this we will investigate the rates of colorectal cancer and pre-cancerous growths in this population, and the usefulness of the two screening tests for this group of patients.
Trial website
Trial related presentations / publications
Preliminary results from the study have been presented in abstract form at the following conferences:
1. The Transplantation Society Congress, August 2010 (Vancouver, Canada)
2. Australian and New Zealand Society of Nephrology Annual Scientific Meeting, September 2010 (Perth, Australia)
2. American Transplant Congress, May 2011 (Philadelphia, USA)
2. Transplantation Society of Australia and NZ, June 2011 (Canberra, Australia)
Public notes

Contacts
Principal investigator
Name 28426 0
Address 28426 0
Country 28426 0
Phone 28426 0
Fax 28426 0
Email 28426 0
Contact person for public queries
Name 11583 0
Dr Michael Collins
Address 11583 0
Central Northern Adelaide Renal and Transplantation Service,
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 11583 0
Australia
Phone 11583 0
+61 8 82220900
Fax 11583 0
+61 8 82220970
Email 11583 0
[email protected]
Contact person for scientific queries
Name 2511 0
Dr Michael Collins
Address 2511 0
Central Northern Adelaide Renal and Transplantation Service,
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 2511 0
Australia
Phone 2511 0
+61 8 82220900
Fax 2511 0
+61 8 82220970
Email 2511 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.