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Early detection of colorectal cancer (CRC) through screening is the most effective method to reduce morbidity as well as mortality from this disease. Fecal immunochemical test (FIT)-based screening has shown to be effective, especially in multi-round population-based screening. However, its sensitivity and specificity are suboptimal, leaving room for improvement. In this perspective, the development journey of a new screening test, the multitargetFIT (mtFIT), which outperforms FIT, is described from discovery down to large-scale clinical utility testing and health technology assessment.

Background Many screening programs for colorectal cancer (CRC) use the fecal immunochemical test (FIT) to triage individuals for colonoscopy. Although these programs reduce CRC incidence and CRC-related mortality, the detection of advanced precursor lesions (advanced adenomas and advanced serrated polyps) by FIT could be improved. As an alternative for FIT, the antibody-based multitargetFIT (mtFIT) has been proposed. The mtFIT measures three protein markers: hemoglobin, calprotectin, and serpin family F member 2. In a retrospective diagnostic accuracy study in a large colonoscopy-controlled series ( n  = 1284), mtFIT showed increased sensitivity for advanced neoplasia (AN), at equal specificity, compared to FIT (42.9% versus 37.3%; p  = 0.025). This increase was mainly due to a higher sensitivity of mtFIT for advanced adenomas (37.8% versus 28.1% for FIT; p  = 0.006). The present mtFIT study aims to prospectively validate these findings in the context of the Dutch national CRC screening program. Method The mtFIT study is a cross-sectional intervention study with a paired design. Eligible subjects for the Dutch FIT-based national CRC screening program are invited to perform mtFIT in addition to FIT. Samples are collected at home, from the same bowel movement, and are shipped to a central laboratory by postal mail. If either one or both tests are positive, participants are referred for colonoscopy. Detailed colonoscopy and pathology data are centrally stored in a national screening database (ScreenIT; Topicus, Deventer, the Netherlands) that is managed by the screening organization, and will be retrieved for this study. We aim to determine the relative sensitivity for AN, comprising of CRC, advanced adenomas and advanced serrated polyps, of mtFIT compared to FIT at an equal positivity rate. Additionally, we will use the Adenoma and Serrated Pathway to Colorectal CAncer model to predict lifetime health effects and costs for programmatic mtFIT- versus FIT-based screening. The target sample size is 13,131 participants. Discussion The outcome of this study will inform on the comparative clinical utility of mtFIT versus FIT in the Dutch national CRC screening program and is an important step forward in the development of a new non-invasive stool test for CRC screening. Trial registration Clinicaltrials.gov ; NCT05314309, registered April 6th 2022, first inclusions March 25th 2022 https://clinicaltrials.gov/ct2/results?cond=&term=NCT05314309&cntry=&state=&city=&dist =.

Background Guidelines of the American Cancer Society and US Preventive Services Task Force specify that colorectal cancer (CRC) screening using guaiac‐based fecal occult blood test (FOBT)/fecal immunochemical test (FIT) should be done at home. We therefore examined the prevalence and correlates of CRC screening using FOBT/FIT in physicians' office vs at home. Methods Analysis of 9493 respondents 50‐75 years old from the Cancer Control Supplement of the 2015 National Health Interview Survey was conducted. Weighted multivariable logistic regression was used to identify the determinants of in‐office vs home use of FOBT/FIT for CRC screening. Results Of the overall sample of screening‐eligible adults (n = 9403), only 937 (10.4%) respondents underwent CRC screening using FOBT/FIT within the past year; among this screening population, 279 (28.3%) respondents were screened in‐office. We found that sociodemographic factors alone, not CRC risk factors, determined whether FOBT/FIT would be used in‐office or at home. Hispanics had greater odds of being screened in‐office using FOBT/FIT (aOR: 2.04; 95% CI: 1.05‐3.99). Compared with those 50‐59 years old, respondents 70‐75 years old were less likely to be screened in‐office using FOBT/FIT (aOR: 0.44, 95% CI: 0.25‐0.79). Similarly, individuals residing in the Western region of the country had lower odds of in‐office FOBT/FIT (aOR: 0.26; 95% CI: 0.11‐0.58). Conclusion Amid low overall uptake rates of FOBT/FIT in the United States, in‐physician office testing is high, indicative of a missed opportunity for effective screening and poor adherence of physicians to national guidelines. Sociodemographic factors are determinants of uptake of FOBT/FIT at home or in‐office and should be considered in designing interventions aimed at providers and the general population. Amid low overall uptake rates of FOBT/FIT in the United States, in‐physician office testing is high, indicative of a missed opportunity for effective screening and poor adherence of physicians to national guidelines.

Background Faecal immunochemical tests (FITs) are used to triage primary care patients with symptoms that could be caused by colorectal cancer for referral to colonoscopy. The aim of this study was to determine whether combining FIT with routine blood test results could improve the performance of FIT in the primary care setting. Methods Results of all consecutive FITs requested by primary care providers between March 2017 and December 2020 were retrieved from the Oxford University Hospitals NHS Foundation Trust. Demographic factors (age, sex), reason for referral, and results of blood tests within 90 days were also retrieved. Patients were followed up for incident colorectal cancer in linked hospital records. The sensitivity, specificity, positive and negative predictive values of FIT alone, FIT paired with blood test results, and several multivariable FIT models, were compared. Results One hundred thirty-nine colorectal cancers were diagnosed (0.8%). Sensitivity and specificity of FIT alone at a threshold of 10 μg Hb/g were 92.1 and 91.5% respectively. Compared to FIT alone, blood test results did not improve the performance of FIT. Pairing blood test results with FIT increased specificity but decreased sensitivity. Multivariable models including blood tests performed similarly to FIT alone. Conclusions FIT is a highly sensitive tool for identifying higher risk individuals presenting to primary care with lower risk symptoms. Combining blood test results with FIT does not appear to lead to better discrimination for colorectal cancer than using FIT alone.

ObjectiveTo determine whether a faecal immunochemical test (FIT) for faecal haemoglobin concentration (f-Hb) can be safely implemented in primary care as a rule-out test for significant bowel disease (SBD) (colorectal cancer (CRC), higher risk adenoma (HRA) and inflammatory bowel disease (IBD)) when used as an adjunct to the clinical assessment of new bowel symptoms.DesignSingle-centre prospective cohort study of all patients who attended primary care and submitted a FIT in the first calendar year of the service beginning December 2015. f-Hb was estimated using HM-JACKarc (Kyowa Medex) with a clinical cut-off of ≥10 µg Hb/g faeces. Incident cases of CRC were verified via anonymised record linkage to the Scottish Cancer Registry.Results5422 patients submitted 5660 FIT specimens, of which 5372 were analysed (positivity: 21.9%). 2848 patients were referred immediately to secondary care and three with f-Hb <10 µg/g presented acutely within days with obstructing CRC. 1447 completed colonoscopy in whom overall prevalence of SBD was 20.5% (95 CRC (6.6%), 133 HRA (9.2%) and 68 IBD (4.7%)); 6.6% in patients with f-Hb <10 µg/g vs 32.3% in patients with f-Hb ≥10 µg/g. One CRC was detected at CT colonoscopy. 2521 patients were not immediately referred (95.3% had f-Hb <10 µg/g) of which four (0.2%) later developed CRC. Record linkage identified no additional CRC cases within a follow-up period of 23–35 months.ConclusionIn primary care, measurement of f-Hb, in conjunction with clinical assessment, can safely and objectively determine a patient’s risk of SBD.

Colorectal cancer (CRC) is the third most common cancer worldwide. The incidence of CRC is rising in low- and middle-income countries but decreasing in high-income countries due to the widespread use of surveillance colonoscopy. In Africa, the implementation of screening programs remains a challenge, even in countries, such as Ghana that have established CRC screening guidelines. The purpose of this review was to identify the barriers and recommend strategies for implementing CRC screening in African countries. A literature search using PubMed was conducted with the following search terms: colorectal neoplasm, early detection of cancer, mass screening, colonoscopy, faecal occult blood test, faecal immunochemical test (FIT) and Africa. After inclusion and exclusion criteria were applied, a total of 13 articles were reviewed. The most common barriers reported were limited endoscopic capacity, poor knowledge of CRC and CRC screening, health care factors, cultural factors and sociodemographic factors. Recommendations to increase the availability of CRC screening tests were to include the use of FITs, to provide more training for health care providers, and to expand educational programs for patients, physicians, and religious/community leaders. The primary barrier to screening for CRC in Africa is the limited endoscopic capacity, specifically the lack of infrastructure and trained personnel, which requires systematic changes by governing bodies. In addition, health care professionals should be involved in educating patients about CRC and CRC screening. Further research is needed to clarify the factors related to subtypes of CRC and to explore the feasibility of using FITs in Africa.

This study presents and explores the potential of Updated Bayesian Deduction (UBD) using colorectal cancer (CRC) detection and prioritisation as a case example. Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide, and its prognosis strongly depends on early detection and timely treatment. In Chile, colonoscopy waiting lists for patients in public hospitals can exceed one year, limiting access to early diagnosis and reducing survival rates. Traditional single-test screening strategies, such as a single faecal immunochemical test (FIT), often yield uncertain results, contributing to inefficiencies in resource allocation. We propose a deductive approach that integrates evidence from multiple sequential and independent FITs to dynamically update the posterior probability of CRC. A case study is analysed with this Updated Bayesian Deduction over a four-round FIT protocol to assess how this could improve risk stratification compared to standard symptoms-based screening. Our mathematical model shows that over 85% of colonoscopies for symptomatic patients were not urgent. We then demonstrate that, if 4-FIT UBD were used to screen Chile's Metropolitan Region population, only 96 out of 100,000 people would require an urgent colonoscopy to detect the 19.6 out of 100,000 individuals with CRC in this region. Many countries cannot afford a colonoscopy-based population screening, such as what is performed in Germany. Performing 4x FITs + a very small number of colonoscopies would be much more affordable and would get more countries to adopt general CRC screening. In countries with limited colonoscopy availability, such as Chile, where symptomatic patients can wait over a year for treatment in public hospitals, implementing a UBD-based strategy could drastically reduce costs and optimise the use of resources. This would improve access to colonoscopies for critical cases and ultimately enhance five-year survival rates. These findings highlight UBD as a promising approach for evidence-based precision medicine in CRC screening and prioritisation that is both explainable and adaptable.

Colorectal cancer (CRC) screening uptake was low in Singapore. An automated kiosk (KIPFIT) dispensing Faecal Immunochemical Test (FIT) kits was developed to facilitate CRC screening. A prospective observational study leveraged on case-encounter approach to recruit community-dwelling adults aged 50–85 years. They were guided to collect two FIT kits from the kiosk on passing by a local multi-purpose mall. The study aimed to determine their CRC screening uptake by returning minimally one completed kit within two months after its collection. Data on their demographics, awareness, and prior screening history, and kiosk usability (as measured by the System Usability Scale SUS) were analysed using bivariate tests, followed by logistic regression for CRC screening completion and linear regression for SUS scores. Among the 350 participants (mean age 66.1 years; 57.4% female; 91.4% Chinese), 68.9% completed CRC screening, which was associated with Chinese ethnicity (AOR = 3.13, 95%CI = 1.42–6.90) and awareness of screening (AOR = 2.18, 95%CI = 1.10–4.33). Benchmarked at 68, the mean SUS score was 57.7, with lower scores in older and lower-educated participants. Guided use of the KIPFIT kiosk had increased CRC screening uptake. Further research is needed to assess its utility without assistance and its effects on CRC screening in real-world setting.

Background Colorectal cancer (CRC) is the third most common cancer and the fourth most common cause of cancer deaths globally. However, there is overwhelming evidence that a large proportion of CRC cases and deaths could be prevented by screening. Nevertheless, CRC screening programmes are offered in a minority of countries only and often suffer from low adherence. Discussion Factors potentially accounting for hesitant implementation of and low adherence to CRC screening may include a lower attention in the public and the media than for other cancers and the fairly long follow-up time needed to fully disclose screening effects on CRC incidence and mortality. The latter results from the very slow development of most CRCs through the adenoma-carcinoma sequence, and it challenges the predominant or even exclusive reliance on evidence from randomized controlled trials in policy decisions on screening offers. Additional key elements of future research should include (1) studies evaluating diagnostic performance of novel biomarkers for non-invasive or minimally invasive CRC screening in true screening settings, (2) modelling studies evaluating expected short- and long-term impact, effectiveness, and cost-effectiveness of various screening options, and (3) timely and close monitoring of process quality and outcomes of existing and planned CRC screening programmes. Most importantly, however, translation of the vast existing evidence on CRC screening into actual screening programmes with the best possible levels of adherence needs to be fostered. This can be best achieved in the context of organized programmes. Depending on available infrastructure and resources, epidemiological patterns, population preferences, and costs, different screening offers might be preferred. According to current evidence, colonoscopy, flexible sigmoidoscopy, and faecal occult blood tests (preferably faecal immunochemical tests) are prime candidates for effective and cost-effective screening options, and microsimulation models should help to tailor their implementation. Summary The strong evidence for the large potential of CRC screening in reducing the burden of CRC calls for timely implementation of organized screening programmes where they are not in place yet, and for continuous improvement of existing ones. This should be considered an obligation that is not to be postponed: the time to act is now.

Background: Organised colorectal cancer (CRC) screening programmes have been widely implemented across Europe; however, robust population-level evaluations of their real-world effectiveness, particularly for programmes based exclusively on faecal immunochemical testing (FIT), remain limited. The Galician CRC screening programme was progressively implemented between 2013 and 2019. Methods: We conducted a population-based ecological time-series study using data from the Galician Tumour Registry (ICD-10 C18–C21) for 2015–2023. Age-standardised mortality (ASMR) and incidence (ASIR) rates were analysed. They were calculated using the direct standardisation method, applying age-specific rates to the 2013 European Standard Population (ESP2013). Structural changes associated with programme implementation were evaluated using interrupted time-series (ITS) models, estimating annual percent change (APC) before and after implementation and the net change in slope (ΔAPC). Absolute and relative changes in ASMR and ASIR were calculated by comparing 2015–2017 and 2019–2023. Analyses were performed for the overall population and for individuals aged 50–69 years. Results: Between 2015 and 2023, overall CRC mortality declined significantly (APC −3.00%; 95% CI −3.37 to −2.63). ITS analysis demonstrated a marked modification of mortality trajectories following programme implementation. Mortality shifted from an increasing pre-implementation slope (APC +13.70%; 95% CI 10.12, 17.39) to a significant annual decline post-implementation (APC −3.62%; 95% CI −4.47, −2.76), yielding a ΔAPC of −17.32. In individuals aged 50–69 years, the structural change was more pronounced (ΔAPC −19.88), with post-implementation mortality decreasing by −8.08% annually (95% CI −10.43, −5.66). Incidence showed a comparable structural modification. Overall APC changed from +15.26% (95% CI 5.48, 25.95) before implementation to −2.48% (95% CI −5.29, 0.41) afterwards (ΔAPC −17.74). In the screening-eligible population, APC shifted from +21.32% (95% CI 4.60, 40.71) to −3.74% (95% CI −7.62, 0.30), corresponding to a ΔAPC of −25.06. Descriptively, ASMR declined from 41.92 to 35.91 per 100,000 (−14.33%), and ASIR from 98.37 to 85.16 per 100,000 (−13.42%) between 2015 and 2017 and between 2019 and 2023. Relative reductions were larger in individuals aged 50–69 years and were more pronounced for colon cancer than for rectal cancer. Conclusions: Implementation of an organised FIT-based screening programme was associated with a structural change in CRC mortality and incidence trends, particularly among individuals aged 50–69 years.