Screening for colorectal cancer in the Netherlands;a study comparing attendance and feasibility of two different forms of faecal occult blood testing and sigmoidoscopy.
Ontology highlight
ABSTRACT:
DISEASE(S): Attendance,Screening,Colorectal Cancer
PROVIDER: 15493 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Study hypothesis: Comparisons of attendance, detection rates and acceptability of total colonoscopy, flexible sigmoidoscopy and fecal occult blood test (FOBT) as primary screening tests for colorectal cancer.
Primary outcome(s): Attendance and detection rate to total colonoscopy, flexible sigmoidoscopy and FOBT as primary screening tests.
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Project description:Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.
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Project description:Interventions: Immunochemical fecal occult blood test (FIT) using OC sensor io (Eiken co)
Primary outcome(s): Diagnostic sensitivity of immunochemical fecal occult blood test (FIT) for colorectal cancers based on the location, staging, tumor size and macroscopic types.
Study Design: Single arm Non-randomized
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Project description:Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts with human globin, a protein that is digested by upper GI enzymes and is specific for detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI pathologies, the adjuncts of G-FOBT and H. pylori stool-antigen test (HpSA) may be a potential candidate to realize a pan-detecting assay based on stool samples in a population in which both lower and upper GI lesions are equally prevalent.
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Project description:Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and affects men and women almost equally. The United States Preventative Services Task Force (USPSTF) currently recommends screening with any of three options, which include fecal testing, flexible sigmoidoscopy, or colonoscopy.
Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually or biennially has been shown to decrease mortality 15-33% primarily through detection of early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of benefit and risk in screening populations, is the least expensive, and is the preferred method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers significant improvements over the gFOBT, most notably that it is easier to use (requires fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved test performance and usability, in 2008 multiple professional societies endorsed the use of four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro FIT as the fecal screening test in all regions.
In recent years, intensive efforts have been undertaken to identify blood-based markers that may provide a promising alternative or supplement to fecal testing for non-invasive CRC screening. One method under development is to identify aberrantly methylated genes in cancer tissue through a blood test. Prior studies have explored those specific colorectal cancer genes that show the highest differences in methylation between the cancer and background genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is relatively well studied.
The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded colonoscopies. The population of interest for this study-those with a positive screening OC-Micro fecal immunochemical test-has a CRC prevalence of approximately 5%. Knowing how well Septin 9 can identify those without cancer prior to colonoscopy is important largely because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause serious complications.
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Project description:The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.
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Project description:Study hypothesis: The efficacy of colorectal cancer screening (CRCS) using faecal occult blood test (FOBT) in reducing colorectal cancer (CRC) mortality in a population at generic risk, has been shown in several large randomized trials.
The screening programs need to contact the whole target population and involve as many people as possible in order to be actually effective. The scientific literature about the reasons for non-compliance have generated few definitive operational recommendations.
Two types of FOBT are now available: the Guaiac and the Immunochemical test. The sensitivity and specificity of the two tests are similar and do not clearly indicate which one is better for screening. The price of the immunochemical test is actually about 1.5 times higher than the Guaiac, but there are no data about the costs per person screened. The Guaiac test recommends three different evacuations, and requires the patient to store the samples, and follow dietary restrictions. The immunochemical test is recommended on a single evacuation and does not require dietary restrictions. The discomfort and embarrassment of faecal sampling and the dietary restrictions have been hypothesized to be determinants of non-compliance. This background may determine lower compliance to the Guaiac test.
Several guidelines for screening programme implementation recommend the involvement of general practitioners (GP) and family practitioners (FP); nevertheless the role of the GPs and FPs varies between countries and health service organizations, making this recommendation hard to implement. The Agency for Public Health of Lazio, Italy, decided to design a trial phase in order to plan an evidence-based implementation of the CRCS program. The aim of this approach is to guarantee that the efficacy of CRCS can be translated to effectiveness in a public health intervention. The screening strategy adopted was: yearly FOB testing for 5074 year olds and, for positives, colonoscopy. A special focus was how to obtain a high compliance to screening; the topics studied were: GPs attitudes and practices, type of FOBT, test provider, and the individual reasons.
Studies included: a survey, a randomized factorial trial nested in the survey, and a casecontrol study nested in the trial.
Primary outcome(s): Compliance to screening: (number of returned faeces samples)/(total number of invited subjects)
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Project description:Cancer is the most common disease around the world and colorectal cancer is the second most common cancer. The early diagnosis of colorectal cancer is difficult and relies on invasive diag-nostic tools such as colonoscopy and tissue biopsy. Other non-invasive techniques such as fecal occult blood screening test (FOBT) are less sensitive and accurate. The advantage of FOBT together with high throughput technology such as metabolomics could provide the advantages of non-invasive tool and the effectiveness of detecting novel colorectal cancer markers. In this way, this work focuses on the novelty of using FOBT as samples to perform metabolomics analysis and its application on colorectal cancer population.
2022-12-09 | ST002468 | MetabolomicsWorkbench
Project description:The objective of this study is to compare the performance characteristics or accuracy of different in-home screening tests for colorectal cancer (fecal occult blood tests), among patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria and agree to participate in the study are asked to perform one guaiac and two immunochemical fecal occult blood tests at home prior to their colonoscopy. After the patient has completed and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy. Accuracy and performance characteristics for each type of fecal occult blood test, including sensitivity, specificity, test positivity rate and positive predictive value for advanced colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.
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Project description:In this randomised placebo-controlled trial, irritable bowel syndrome (IBS) patients were treated with faecal material from a healthy donor (n=8, allogenic FMT) or with their own faecal microbiota (n=8, autologous FMT). The faecal transplant was administered by whole colonoscopy into the caecum (30 g of stool in 150 ml sterile saline). Two weeks before the FMT (baseline) as well as two and eight weeks after the FMT, the participants underwent a sigmoidoscopy, and biopsies were collected at a standardised location (20-25 cm from the anal verge at the crossing with the arteria iliaca communis) from an uncleansed sigmoid. In patients treated with allogenic FMT, predominantly immune response-related genes sets were induced, with the strongest response two weeks after FMT. In patients treated with autologous FMT, predominantly metabolism-related gene sets were affected.
2019-10-14 | GSE138297 | GEO