Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Neoplasm,Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2072705 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: 1-sample or 2-samples immunochemical FOBTs.
Firstly, a representative population sample of 2.500 asymptomatic persons between
50-75 years of age in the region ‘Rijnmond’ will be invited for the 1st screening round using 1-sample iFOBT in 2008 and for a 2nd screening round after one year (group A).
Secondly, the 5.000 asymptomatic persons who were invited in our first trial for a 1st-round one-sample iFOBT in 2006/2007 (NTR = 1096), will be invited for 2nd round screening. They will be pre-randomized for biennial (group B) or triennial (group C) 2nd round screening. The attendance rate of these two groups will be compared with the participation of the second screening round from group A.
Furthermore, 3.200 newly randomly selected persons will be invited for a single 1st round screening using 2-sample iFOBT (group D). The attendance rate of this group will be compared with the participation of the first screening round from group A.
Primary outcome(s): Adherence for second round CRC screening with 1-sample iFOBT (OC-Hemodia Latex) comparing annual, biennial, and triennial screening interval.
Adherence and diagnostic yield of a first screening round comparing 1-sample versus 2-sample iFOBT screening.
Study Design: Randomized controlled trial, Open (masking not used), N/A , unknown, Parallel
| 15872 | ecrin-mdr-crc
Project description:We compared gene expression in axillary buds from annual and biennial flowering raspberry to identify differentially expressed genes.
2019-08-17 | GSE135907 | GEO
Project description:Colorectal cancer (CRC) is a major cause of death in Sweden. There are approximately 6000 new cases each year in Sweden and the disease specific mortality is more than 40%. There risk is about 1% to develop CRC between 60-70 years of age making 60-year olds a suitable target population for colorectal cancer screening.
The Swedish ministry of health and social affairs proposed a national study on the efficiency of colorectal cancer screening in the Swedish population regarding mortality, but also what screening method to be used. Eighteen participating counties of Sweden now fund the study to be launched in 2014.
From the Register of the total population individuals 59-62 years of age will be randomized and invited by mail to screening. Thirty- thousand five hundred individuals will be invited to primary colonoscopy and 60 000 individuals will be invited to high sensitive FIT (approximately 10% positive) and if positive to a subsequent follow-up colonoscopy. If test negative a second round of FIT will be asked for in two years. In total 183 000 randomized individuals will not be invited to screening, but followed in the Swedish Cancer register and serve as controls. The inclusion period I set to five years (five years with the second round of FIT) generating approximately 5 000 colonoscopies yearly the first three years and 1200 year four and five at a compliance rate of 35% in the colonoscopy arm and 50% in the FIT arm.
Follow-up time is set to 15 years with the primary endpoint disease specific mortality, but also incidence. Secondary outcomes by others to be studied are in short quality assurance variables of colonoscopy, participants and non-participants experiences of the invitation and the screening procedure, health economy measures of the CRC-screening study and when implemented in clinical care.
| 2162036 | ecrin-mdr-crc
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.
| 2260843 | ecrin-mdr-crc
Project description:Interventions: Group 1: One-time survey in April/May 2020 of 50- to 60 years old statutory insured persons with a written, self administered questionnaire consisting of a) sociodemographic and health-related items, b) the discrete choice experiment and c) items asking for the intention to participate and the preferred colorectal cancer screening test.
Primary outcome (first project phase - discrete-choice experiment):
Estimating the contribution of attributes and levels to overall utility (part-worth utilities).
Primary outcome (second project phase - decision analytic modelling):
Cost-effectiveness of an extended screening strategy (iFOBT, colonoscopy, sigmoidoscopy) compared to the current colorectal cancer screening program (iFOBT, colonoscopy).
Study Design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose:
| 2436138 | ecrin-mdr-crc
Project description: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
| 2456994 | ecrin-mdr-crc
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