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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.

Uptake of colorectal cancer screening remains suboptimal. Mailed fecal immunochemical testing (FIT) offers promise for increasing screening rates, but optimal strategies for implementation have not been well synthesized. In June 2019, the Centers for Disease Control and Prevention convened a meeting of subject mat-ter experts and stakeholders to answer key questions regarding mailed FIT imple-mentation in the United States. Points of agreement included: 1) primers, such as texts, telephone calls, and printed mailings before mailed FIT, appear to contribute to effectiveness; 2) invitation letters should be brief and easy to read, and the signa-tory should be tailored based on setting; 3) instructions for FIT completion should be simple and address challenges that may lead to failed laboratory processing, such as notation of collection date; 4) reminders delivered to initial noncompleters should be used to increase the FIT return rate; 5) data infrastructure should identify eligible patients and track each step in the outreach process, from primer delivery through abnormal FIT follow-up; 6) protocols and procedures such as navigation should be in place to promote colonoscopy after abnormal FIT; 7) a high-quality, 1-sample FIT should be used; 8) sustainability requires a program champion and organizational support for the work, including sufficient funding and external policies (such as qual-ity reporting requirements) to drive commitment to program investment; and 9) the cost effectiveness of mailed FIT has been established. Participants concluded that mailed FIT is an effective and efficient strategy with great potential for increasing colorectal cancer screening in diverse health care settings if more widely imple-mented.

Background/Aim: Noninvasive fecal occult blood tests (FOBTs) are recommended by current guidelines for colorectal cancer (CRC) screening. Our aim was to assess the diagnostic performance of traditional guaiac-based FOBTs (gFOBT) and new-generation immunochemical FOBTs (iFOBT) in CRC screening by carrying out a systematic review and meta-analysis. Patients and Methods: PubMed, Embase, Cochrane Library, and Web of Science were searched for eligible articles published before February 17, 2020. Three independent investigators conducted study assessment and data extraction. Diagnosis-related indicators for use of FOBTs in the detection of CRC (as the endpoint) in a screening setting were summarized, and further stratified by the type of FOBT (gFOBT vs. iFOBT). STATA software was used to conduct the meta-analysis. Pooled sensitivities and specificities were calculated using a random-effects model. Hierarchical summary receiver operating characteristic curves were plotted and area under the curves (AUC) were calculated. Results: The electronic search identified 573 records after duplicates were removed, of which 75 full-text articles were assessed for eligibility. Finally, a total of 31 studies were eligible for the meta-analysis. In the ROC comparison test, there was a statistically significant difference in the performance of gFOBT and iFOBT tests, with AUC=0.77 (95% confidence intervaI=0.75-0.79) and AUC=0.87 (95% confidence intervaI=0.85-0.88), respectively (p=0.0017). In formal meta-regression, test brand did not prove to be a significant study-level covariate that would explain the observed heterogeneity between the studies. Conclusion: New-generation iFOBTs were found to have a significantly higher diagnostic performance as compared with gFOBTs, advocating the use of only fecal immunochemical tests in all newly implemented CRC screening programs.

Background Biomarkers have revolutionized the management of colorectal cancer (CRC), facilitating early detection, prevention, personalized treatment, and minimal residual disease (MRD) monitoring. This review explores current CRC screening strategies and emerging biomarker applications. Main body. We summarize the landscape of non-invasive CRC screening and MRD detection strategies, discuss the limitations of the current approaches, and highlight the promising potential of novel biomarker solutions. The fecal immunochemical test remained the cornerstone of CRC screening, but its sensitivity has been improved by assays that combined its performance with other stool analytes. However, their sensitivity for advanced adenomas and the patient compliance both remain suboptimal. Blood-based tests promise to increase compliance but require further refinement to compete with stool-based biomarker tests. The ideal scenario involves leveraging blood tests to increase screening participation, and simultaneously promote stool- and endoscopy-based screening among those who are compliant. Once solely reliant on upfront surgery followed by stage and pathology-driven adjuvant chemotherapy, the treatment of stage II and III colon cancer has undergone a revolutionary transformation with the advent of MRD testing after surgery. A decade ago, the concept of using a post-surgical test instead of stage and pathology to determine the need for adjuvant chemotherapy was disruptive. Today, a blood test may be more informative of the need for chemotherapy than the stage at diagnosis. Conclusion Biomarker research is not just improving, but bringing a transformative change to CRC clinical management. Early detection is not just getting better, but improving thanks to a multi-modality approach, and personalized treatment plans are not just becoming a reality, but a promising future with MRD testing.

Colorectal cancer (CRC) is the third most common form of cancer in terms of incidence and the second in terms of mortality worldwide. CRC develops over several years, thus highlighting the importance of early diagnosis. National screening programs based on fecal occult blood tests and subsequent colonoscopy have reduced the incidence and mortality, however improvements are needed since the participation rate remains low and the tests present a high number of false positive results. This review provides an overview of the CRC screening globally and the state of the art in approaches aimed at improving accuracy and participation in CRC screening, also considering the need for gender and age differentiation. New fecal tests and biomarkers such as DNA methylation, mutation or integrity, proteins and microRNAs are explored, including recent investigations into fecal microbiota. Liquid biopsy approaches, involving novel biomarkers and panels, such as circulating mRNA, micro- and long-non-coding RNA, DNA, proteins and extracellular vesicles are discussed. The approaches reported are based on quantitative PCR methods that could be easily applied to routine screening, or arrays and sequencing assays that should be better exploited to describe and identify candidate biomarkers in blood samples.

Previous randomized studies suggest that fecal occult blood test (FOBT) screening can reduce mortality from colorectal cancer (CRC). Our aim was to review the current status of FOBTs in CRC screening. FOB is measured using either the traditional guaiac-based tests or more recently introduced fecal immunochemical tests (FITs). FITs have several advantages over guaiac-based FOBTs, including higher sensitivity and specificity, resulting in improved clinical performance and higher efficiency. Another advantage in population screening according to European Guidelines for quality assurance in CRC screening is that FITs can be automated and user can adjust the cut-off at which a positive result is reported. In population-based screening, all those testing positively with any FOBT should be referred for colonoscopy. Conclusion: Although a plethora of FOBTs are available on the market, relatively few have been extensively tested for clinical sensitivity and specificity in CRC screening. Current data imply that new FITs have superior test characteristics as compared with guaiac-based FOBTs. The latest development in the field is represented by the proteomic-based tests that may further reduce false-negative rates in CRC screening. Simple stool sample preservation and automatic analysis are other important issues in population-based screening for CRC.

Background/Aim: The aim of this study was to assess the diagnostic accuracy (DA) of a ColonView (CV) test in proximal versus distal colorectal adenoma (pCRA versus dCRA). Patients and Methods: The colorectal neoplasia (CRN) screening cohort included 5,090 individuals and 506/5,090 (10%) were eligible for the study. Finally, only 127/506 were included in the CRA analysis and hierarchical summary ROC (HSROC) curves were used to show the pooled overall DA of visually analyzed (VA) and automatically analyzed (AA) techniques in pCRA and dCRA detection. Results: The overall specificity (Sp) of the AA technique for the pCRA and dCRA endpoint was 46% and 43%, respectively. The most sensitive AA test in pCRA patients showed 76% sensitivity (Se) versus 58% Se in dCRA patients. In the HSROC analysis, area under the curve (AUC) values were as follows: i) VA in pCRA: AUC=0.503, ii) AA in pCRA: AUC=0.560, iii) VA in dCRA: AUC=0.552 and iv) AA in dCRA: AUC=0.486. In Roccomp analysis, the statistically significant AUC values were available between VA and AA reading modes in pCRA (p=0.044) and in AA reading between pCRA and dCRA (p=0.024). Conclusion: As compared with the CRC endpoint, the DA value of the CV test is far inferior for the CRA endpoint, as determined by the AUC values.

PurposeWe assessed fecal immunochemical test (FIT) uptake following a mailed FIT intervention among 45–49-year-olds newly eligible for colorectal cancer (CRC) screening based on 2021 United States Preventive Services Task Force screening recommendations. We also tested the effect of an enhanced versus plain mailing envelope on FIT uptake.MethodsIn February 2022 we mailed FITs to eligible 45–49-year-olds at one Federally Qualified Health Center (FQHC) clinic. We determined the proportion who completed FITs within 60 days. We also conducted a nested randomized trial comparing uptake using an enhanced envelope (padded with tracking label and colored messaging sticker) versus plain envelope. Finally, we determined the change in CRC screening by any modality (e.g., FIT, colonoscopy) among all clinic patients in this age group (i.e., clinic-level screening) between baseline and 6 months post-intervention.ResultsWe mailed FITs to 316 patients. Sample characteristics: 57% female, 58% non-Hispanic Black, and 50% commercially insured. Overall, 54/316 (17.1%) returned a FIT within 60 days, including 34/158 (21.5%) patients in the enhanced envelope arm versus 20/158 (12.7%) in the plain envelope arm (difference 8.9 percentage points, 95% CI: 0.6–17.2). Clinic-level screening among all 45–49-year-olds increased 16.6 percentage points (95% CI: 10.9–22.3), from 26.7% at baseline to 43.3% at 6 months.ConclusionCRC screening appeared to increase following a mailed FIT intervention among diverse FQHC patients aged 45–49. Larger studies are needed to assess acceptability and completion of CRC screening in this younger population. Visually appealing mailers may improve uptake when implementing mailed interventions.Trial registration The trial was registered on May 28, 2020 at ClinicalTrials.gov (identifier NCT04406714).

Background/Aim: The present study compared the accuracy of visually analyzed (VA) and automatically analyzed (AA) ColonView (CV) quick test; a new-generation fecal immunochemical test (FIT) for hemoglobin (Hb) and hemoglobin/haptoglobin (Hb/Hp) (Biohit Oyj, Helsinki, Finland) in subjects participating in colorectal neoplasia (CRN) detection in Brazil. A traditional guaiac-based fecal occult blood test (gFOBT) test (HemoccultSENSA) was used as a reference. Patients and Methods: A cohort of 509 colonoscopy-referral patients were asked to collect three consecutive fecal samples, to be analyzed by both CV and SENSA. Results: In ROC analysis for the AA reading, the optimal cut-off value for CV Hb was ≥8.0912 and that for CV Hb/Hp was ≥1.8983. With these cut-offs, the sensitivity (Se), specificity (Sp), and efficiency of CV AA in detecting colorectal adenoma (CRA) were: 64.2%/78.6%, 53.4%/35.3%, and 58.6%/56.5%, for Hb and Hb/Hp, respectively. In the HSROC analysis, the AUC values for i) VA and ii) AA modes were as follows: i) AUC=0.551 (95%CI=0.500-0.602), ii) AUC=0.606 (95%CI=0.550-0.662). The difference between these AUC values was statistically significant (p=0.0160). Conclusion: The present study confirms the previous results on the applicability of the ColonView quick test in CRN screening. Of the two optional reading modes, the AA reading showed significantly better diagnostic accuracy as compared to the VA reading (or SENSA), in detecting the CRA endpoint in colonoscopy-referral patients.