None listed
Conditions
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.
Interventions
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,
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.
Sponsors
Dr Germaine Wong
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 74 Years
Healthy volunteers
No
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)
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.
Outcome results
None listed