Dataset Information

Colorectal cancer screening and early detection in people with Chronic Kidney Disease

ABSTRACT: 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, 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, histologica Primary outcome(s): 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. [Five years];Prevalence of colorectal cancer as determined with diagnostic colonoscopy, in people with chronic kidney disease in stages 3-5, dialysis and kidney transplant populations.[Five years];Test performance characteristics of immunochemical faecal occult blood screening, including: test specificity, positive predictive values and negative predictive value for colorectal cancers. [Five years] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): Bowel Cancer,Renal And Urogenital-kidney Disease,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Chronic Kidney Disease

PROVIDER: 2456994 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Colorectal cancer (CRC) is one of the most common types of cancer in Denmark, and mortality among patients is high. Patients presenting with alarm symptoms of CRC are referred to colonoscopy in the cancer patient pathway for CRC. However, the proportion of patients with alarm symptoms who have CRC is below 10%. Simultaneously, the burden on endoscopy units to conduct fast-track colonoscopies is growing. Occult blood in the faeces may be an early sign of cancer or precancerous lesions, and can be detected by an immunochemical faecal occult blood test (iFOBT). Few studies have examined the diagnostic properties of the iFOBT among symptomatic patients, and reported sensitivities ranging from 88%-100%, specificities from 77%-94%, and negative predictive values from 98%-100%. These results were derived from diverse patient populations, and used different cut-offs to define positive test results. Using iFOBT may be a valuable tool for the GP when deciding on referral of the patient to the cancer patient pathway. However, evidence is needed on the diagnostic accuracy of the test to detect CRC among patients presenting with alarm symptoms. Hypothesis: In patients presenting with alarm symptoms of CRC, detection of faecal occult blood by iFOBT is an accurate measure of the presence of colonic lesions. Aim: The aim of the study is to examine the diagnostic accuracy of the iFOBT among symptomatic patients referred to colonoscopy in the cancer patient pathway for CRC. Materials and methods: The project is conducted as a diagnostic accuracy study. Patients appointed for colonoscopy will be invited to collect a faecal sample and mail it for analysis. The iFOBT result will be registered in a computer-based laboratory information system. The result of the colonoscopy will be registered in Danish national health registries. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated as measures of the diagnostic properties of the iFOBT, using the result of colonoscopy as the reference standard. The accuracy of the test by type of alarm symptom will also be assessed. Perspectives: The study will provide new and valuable data to evaluate the referral criteria for the cancer patient pathway. Given a good discriminatory ability of the iFOBT among symptomatic patients, fast-track colonoscopy may not be necessary as a first-choice examination in the diagnostic work-up of these patients.

Project description:Interventions: The intervention is a SMS personalised message from the general practice sent to the patient’s smartphone with links to: 1. A message from the general practitioners (GPs) at the general practice (e.g. Hello. xxx This is a health message from the GPs at xxx Medical Practice. Your free bowel cancer screening kit will arrive in the post soon. We strongly encourage you to do this test. If cancer is detected early over 90% of bowel cancers are successfully treated. We recommend that you watch the videos below.) 2. A video of a person talking about their positive experience of doing the National Bowel Cancer Screening Program (NBCSP) Immunochemical Faecal Occult Blood Test (IFOBT) test 3. A animated video demonstrating how to complete the test 4. Links to information from Cancer Council Australia The SMS is sent from the general practice one month prior to patients 50th, 52nd, 54th, 56th, 58th and 60th birthdays. The intervention period is six months long, there will be 6 rounds of SMS sent during that time to any active patient due to receive their NBCSP kit. Patients will only receive one SMS. The number of patients due to be sent the SMS will be recorded in PEN CAT4 clinical audit software and the number of SMS sent is recorded on the GoShare Plus platform. Data, the number of patients due to receive the SMS and the number of SMS sent is recorded at the general practice. This data is collected by the project manager. Primary outcome(s): The primary outcome will be the proportion of patients who complete the NBCSP after six months from the total number of eligible patients who are about to have their 50th, 52nd, 54th, 56th, 58th, or 60th birthdays. This outcome will be measured by the number of FOBT results sent to the general practice for patients in this age group. Aggregate data (number of FOBTs returned in each age group) will be collected from the electronic medical records. [From commencement of the 6 month intervention period to 6 months after completion of the intervention period. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

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Colorectal cancer screening and early detection in people with Chronic Kidney Disease

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