scholarly journals Fecal Immunochemical Tests for Colorectal Cancer Screening: Is Fecal Sampling from Multiple Sites Necessary?

Cancers ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 400
Author(s):  
Efrat L. Amitay ◽  
Anton Gies ◽  
Korbinian Weigl ◽  
Hermann Brenner

Fecal immunochemical tests (FITs) for hemoglobin (Hb) are increasingly used for colorectal cancer (CRC) screening. Most FIT manufacturers instruct that fecal samples from multiple parts of one bowel movement should be obtained. Our aim was to compare the FIT diagnostic performance based on fecal samples from just one versus two different sites of one bowel movement. A total of 1141 participants of screening colonoscopy provided two fecal samples from two different sites of a single bowel movement for FIT analyses. There was no statistically significant difference in the diagnostic performance of the FIT when either one or both fecal samples were used for analysis, with area under the curve (AUC) for detecting CRC ranging from 0.94 (95% confidence interval (CI) 0.84–0.99) for one FIT to 0.95 (95%CI 0.86–0.99) for a geometric mean of two FITs. The manufacturers’ recommendation of sampling multiple sites of the stool aims to reduce intra-individual Hb variability and improve diagnostic performance. If no such improvement can be achieved, the recommendation for multiple-site sampling might have potential adverse effects on population adherence to FIT-based CRC screening. Our results point to a potential of increasing adherence to FIT screening by simplifying instructions for fecal sampling at no loss of the diagnostic performance.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chang Woo Kim ◽  
Hyunjin Kim ◽  
Hyoung Rae Kim ◽  
Bong-Hyeon Kye ◽  
Hyung Jin Kim ◽  
...  

Abstract Background Prevention and early detection of colorectal cancer (CRC) is a global priority, with many countries conducting population-based CRC screening programs. Although colonoscopy is the most accurate diagnostic method for early CRC detection, adherence remains low because of its invasiveness and the need for extensive bowel preparation. Non-invasive fecal occult blood tests or fecal immunochemical tests are available; however, their sensitivity is relatively low. Syndecan-2 (SDC2) is a stool-based DNA methylation marker used for early detection of CRC. Using the EarlyTect™-Colon Cancer test, the sensitivity and specificity of SDC2 methylation in stool DNA for detecting CRC were previously demonstrated to be greater than 90%. Therefore, a larger trial to validate its use for CRC screening in asymptomatic populations is now required. Methods All participants will collect their stool (at least 20 g) before undergoing screening colonoscopy. The samples will be sent to a central laboratory for analysis. Stool DNA will be isolated using a GT Stool DNA Extraction kit, according to the manufacturer’s protocol. Before performing the methylation test, stool DNA (2 µg per reaction) will be treated with bisulfite, according to manufacturer’s instructions. SDC2 and COL2A1 control reactions will be performed in a single tube. The SDC2 methylation test will be performed using an AB 7500 Fast Real-time PCR system. CT values will be calculated using the 7500 software accompanying the instrument. Results from the EarlyTect™-Colon Cancer test will be compared against those obtained from colonoscopy and any corresponding diagnostic histopathology from clinically significant biopsied or subsequently excised lesions. Based on these results, participants will be divided into three groups: CRC, polyp, and negative. The following clinical data will be recorded for the participants: sex, age, colonoscopy results, and clinical stage (for CRC cases). Discussion This trial investigates the clinical performance of a device that allows quantitative detection of a single DNA marker, SDC2 methylation, in human stool DNA in asymptomatic populations. The results of this trial are expected to be beneficial for CRC screening and may help make colonoscopy a selective procedure used only in populations with a high risk of CRC. Trial registration: This trial (NCT04304131) was registered at ClinicalTrials.gov on March 11, 2020 and is available at https://clinicaltrials.gov/ct2/show/NCT04304131?cond=NCT04304131&draw=2&rank=1.


2016 ◽  
Vol 150 (4) ◽  
pp. S456
Author(s):  
David Gibson ◽  
Blathnaid Nolan ◽  
Joanna Rea ◽  
Maire Buckley ◽  
Gareth Horgan ◽  
...  

2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Kei Hirai ◽  
Yoshiki Ishikawa ◽  
Jun Fukuyoshi ◽  
Akio Yonekura ◽  
Kazuhiro Harada ◽  
...  

Abstract Background The purpose of this study was to examine the effectiveness and cost-efficiency of a tailored message intervention compared with a non-tailored message intervention for increasing colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program. Methods After a baseline survey for psychological segmentation, 2140 eligible individuals were randomly assigned either to a group with a tailored matched-message condition (N = 356), a group with a non-tailored unmatched-message condition (N = 355), or to two control groups, one using a typical message with a professional design (N = 717) and one without a professional design (N = 712). The main outcome measure was attendance rates in a community-organized CRC screening program within five months of receiving a print reminder. Results There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219). The cost of a one-person increase in FOBT screening was 3,740 JPY for the tailored matched-message condition, while it was 2,747 JPY for the control. Conclusions A tailored-message intervention for segmented individuals designed to increase CRC screening rates in a community-based client reminder program was significantly effective compared to a usual reminder, but not more effective than an unmatched message in a randomized controlled trial, and was not sufficiently effective to highlight its value from a cost perspective. Therefore, the tailored intervention including target segmentation needs to be improved for future implementation in a CRC screening program for a non-adherent population. Trial registration UMIN Clinical Trials Registry UMIN000004384. Date of Registration: March 2011.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13576-13576
Author(s):  
A. Bononi ◽  
M. Gusella ◽  
G. Crepaldi ◽  
R. Padrini ◽  
E. Ferrazzi

13576 Background: It is well known that females present a significantly reduced clearance of 5FU compared to males treated with the same doses.We tested the hypothesis that it may depend on the hormonal status, so that pre-menopausal women would have different 5FU pharmacokinetics compared with both postmenopausal women and elderly women. Methods: 48 colorectal cancer patients were prospectively studied: all of them were on adjuvant treatment based on 5FU repeated boluses. On the second day of the first cycle peripheral blood was drawn after drug administration. Plasma level were detected by HPLC analysis and pharmacokinetic parameters were calculated trough a one phase exponential decay model. Results: All patients had 100–90 Karnosky Performance status score. 12 were in pre-menopausal phase (age range : 40–55 years); among the others we distinguished a younger 19 people group (age lower than 70 years old) and an elderly 17 patient group (age equal or higher than 70 years old). They received a 5FU mean dose of 406 ± 15 mg/mq, not significantly different among the three groups. After intravenous bolus injection a high interindividual variability of 5-FU pharmacokinetics was detected: AUC0-∞ (area under the curve of drug plasma levels versus time) ranged between 368 and 1236 mg × min/L and the highest values (>1000) were found in two elderly patients, considered fit; anyway there was no significant difference among AUC of the three groups. 5FU total clearance ranged between 0.53 and 1.9 L/min and means were 1.07 ± 0.3, 1.02 ± 0.3 and 0.98 ± 0.3 L/min in pre-menopausal, postmenopausal and elderly women respectively; again 5FU clearance/ BSA (body surface area), half live elimination times and peak concentration plasma levels were not significantly different among the three groups. Conclusions: It seems that sexual hormonal status do not influence 5FU total body elimination capability, and that pharmacokinetic differences between genders should be related to other factors,as for example Body Composition. Funded by AIRC-Veneto No significant financial relationships to disclose.


2021 ◽  
Vol 2 (1) ◽  
pp. 27-34
Author(s):  
Magwaza S

Background This paper maps scientific publications to identify areas of CRC screening that are currently receiving greatest emphasis in South African research, as means, to identify the inequality in CRC screening research. Reviewing the publications can assist to identify research funding and research capacity gaps. It can also identify potential for collaboration of authors and institutions to reduce the inequalities. Methods We used bibliometrics to identify and map the scientific publications on CRC screening related to South Africa (SA).The search utilised three databases, namely: Web of Science, Scopus and PubMed to identify articles published between January 2000 to August 2020. We identified the document by type, research areas, journal type, affiliated countries and research organisations, authors with most publications, and funding sources. Results Forty-eight of the 368 publications were included for bibliometric analysis. Of these, there were 88% original articles; 6% were reviews; 4% were books and 2% were abstracts of meetings. The top CRC screening research areas were oncology (21%); gastroenterology and hepatology (13%), public, environmental, occupational health (13%) and genetics and heredity (13%).The top four journals that have published the CRC screening related to South Africa were the South African Medical J. Surgery (10%); South African Medical Journal (7%); Clinical Genetics (5%) and Colorectal Diseases (5%). 19% of articles were published in 2019. There were 28 (58%) articles with first authors from South Africa. There were ten publications without funding declared (21%). The top five research organisations from South Africa that published the most CRC screening research were University of Witwatersrand (36%); University of Western Cape (18%); University of Pretoria (14%); University of Cape Town and KwaZulu-Natal (11%). Conclusion Research and development of novel CRC screening technologies cannot be overemphasised, as catalyst for diverse screening alternatives that are less invasive, affordable and accessible to all those in need to expand access, coverage and increase uptake at local level. Keywords: Colorectal cancer; Bibliometric; Screening; Colonoscopy; Scientific landscape; Inequalities; Cancer; South Africa.


2020 ◽  
Author(s):  
Thomas Heisser ◽  
Rafael Cardoso ◽  
Feng Guo ◽  
Tobias Moellers ◽  
Michael Hoffmeister ◽  
...  

AbstractObjectiveThe performance of colorectal cancer (CRC) screening programs depends on the adherence to screening offers. However, identical adherence levels may result from varying patterns of the population’s screening behavior. We quantified the effects of different adherence patterns on the long-term performance of CRC screening for annual fecal immunochemical testing (FIT) and screening colonoscopy at ten-year intervals.DesignUsing a multistate Markov model, we simulated scenarios where, while at the same overall adherence level, a certain proportion of the population adheres to all screening offers (‘selective’ adherence) or the entire population uses the screening offers at some point(s) of time, albeit not in the recommended frequency (‘sporadic’ adherence). Key outcomes for comparison were the numbers of prevented CRC deaths and prevented years of potential life lost (YPLL) after 50 simulated years.ResultsFor screening with annual FIT at adherence levels of 10-50%, ratios of prevented CRC deaths (YPLL) resulting from a sporadic versus a selective pattern ranged from 1.9-5.0 (1.9-5.0) for men and from 1.8-4.1 (1.8-4.3) for women, i.e. up to 4-5 times more CRC deaths and YPLL were prevented when the population followed a sporadic instead of a selective adherence pattern. Comparisons of simulated scenarios for screening colonoscopy revealed similar patterns.ConclusionAt the same overall level of adherence, ‘sporadic’ adherence patterns go along with much larger preventive effects than ‘selective’ adherence patterns. Screening programs should prioritize efforts to reach as many people as possible at least sporadically over efforts to maximize full adherence to repeat screening offers. Adherence statistics should be refined to better reflect ‘effective adherence’.What You Need to KnowBACKGROUND AND CONTEXTThe evidence on long-term effects of different patterns of longitudinal adherence (e.g. consistent or sporadic uptake) to colorectal cancer screening offers is limited.NEW FINDINGSIn a simulated hypothetical German population, at identical overall participation levels, large proportions of the population making sporadic use of screening offers were up to 4-5 times more beneficial to achieve sustained reductions of colorectal cancer mortality than small proportions of the population utilizing screening offers at the recommended frequency.LIMITATIONSThis study is limited by model simplifying assumptions and uncertainties related to input parameters.IMPACTEfforts to increase screening uptake should be concentrated on groups of consistent non-responders, e.g. by low-threshold screening offerings, such as directly mailed stool tests. Adherence statistics should be refined to better reflect “effective adherence”.SHORT SUMMARYThis simulation study demonstrates that commonly used adherence metrics for colorectal cancer screening do not sufficiently cover the effect of varying patterns of longitudinal adherence, which may considerably impact the long-term efficacy of screening programs.


2021 ◽  
Vol 8 ◽  
Author(s):  
Ru-chen Zhou ◽  
Pei-zhu Wang ◽  
Yue-yue Li ◽  
Yan Zhang ◽  
Ming-jun Ma ◽  
...  

Objective: The diagnostic efficiency of the quantitative fecal immunochemical test (qFIT) has large variations in colorectal cancer (CRC) screening. We aimed to explore whether the practical sample collection operant training could improve the diagnostic accuracy of the qFIT in CRC screening.Methods: Moderate-/high-risk individuals aged 50–75 years old were invited to participate in a prospective observational study between July 2020 and March 2021. Participants took a qFIT sample without fecal sample collection operant training in advance and then completed another qFIT sample after the operant training. The primary outcome was the sensitivity and specificity of the qFITs for CRC and advanced colorectal neoplasia (ACRN). The secondary outcome was the difference in the area under the curves (AUCs) and the concentrations of the fecal hemoglobin (Hb) between the qFIT without and after the operant training.Results: Out of 913 patients, 81 (8.9%) patients had ACRN, including 25 (2.7%) patients with CRC. For CRC, the sensitivities of the qFIT without and after the operant training at 10 μg/g were 80.4 and 100.0%, respectively, and the specificities were 90.1 and 88.4%, respectively. For ACRN, the sensitivities were 49.4 and 69.1% and the specificities were 91.7 and 91.3%, respectively. The AUC of the qFIT after the operant training was significantly higher than that without the operant training for CRC (p = 0.027) and ACRN (p = 0.001). After the operant training, the concentration of the fecal Hb was significantly higher than that without the operant training (p = 0.009) for ACRN, but there was no significant difference for CRC (p = 0.367).Conclusion: Practical sample collection operant training improves the diagnostic accuracy of the qFIT, which increases the detection of the low concentrations of fecal Hb. Improving the quality of the sample collection could contribute to the diagnostic efficiency of the qFIT in CRC screening.


2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Gang Yu ◽  
Kai Sun ◽  
Chao Xu ◽  
Xing-Hua Shi ◽  
Chong Wu ◽  
...  

AbstractMachine-assisted pathological recognition has been focused on supervised learning (SL) that suffers from a significant annotation bottleneck. We propose a semi-supervised learning (SSL) method based on the mean teacher architecture using 13,111 whole slide images of colorectal cancer from 8803 subjects from 13 independent centers. SSL (~3150 labeled, ~40,950 unlabeled; ~6300 labeled, ~37,800 unlabeled patches) performs significantly better than the SL. No significant difference is found between SSL (~6300 labeled, ~37,800 unlabeled) and SL (~44,100 labeled) at patch-level diagnoses (area under the curve (AUC): 0.980 ± 0.014 vs. 0.987 ± 0.008, P value = 0.134) and patient-level diagnoses (AUC: 0.974 ± 0.013 vs. 0.980 ± 0.010, P value = 0.117), which is close to human pathologists (average AUC: 0.969). The evaluation on 15,000 lung and 294,912 lymph node images also confirm SSL can achieve similar performance as that of SL with massive annotations. SSL dramatically reduces the annotations, which has great potential to effectively build expert-level pathological artificial intelligence platforms in practice.


Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1542 ◽  
Author(s):  
María Marcuello ◽  
Saray Duran-Sanchon ◽  
Lorena Moreno ◽  
Juan José Lozano ◽  
Luis Bujanda ◽  
...  

Early detection of colorectal cancer (CRC) and its precancerous lesion, advanced adenomas (AA), is critical to improve CRC incidence and prognosis. Circulating microRNAs (miRNAs or miR) are promising non-invasive biomarkers for cancer detection. Our previous results showed that a plasma 6-miRNA signature (miR-15b-5p, miR-18a-5p, miR-29a-3p, miR-335-5p, miR-19a-3p and miR-19b-3p) could distinguish between CRC or AA and healthy individuals (controls). However, its diagnostic performance in serum is unknown. In this exploratory study we aim to evaluate the diagnostic performance of the 6-miRNA signature in serum samples in a cohort of individuals participating in Barcelona’s CRC Screening Programme. We prospectively collected serums from 264 faecal immunochemical test (FIT)-positive participants and total RNA was extracted. Finally, 213 individuals (CRC, 59, AA, 74, controls, 80) were included. MiRNA expression was quantified by real-time RT-qPCR and data analysis was performed by logistic regression. Faecal hemoglobin concentration (f(Hb)) from FIT of the same individuals was also considered. As previously described in plasma, serum from patients with AA or CRC presented significant differences in the 6-miRNA signature compared to controls. Moreover, when combined with f(Hb), the final signature showed high discriminative capacity to distinguish CRC from controls (area under the curve (AUC) = 0.88), and even AA (AUC = 0.81) that otherwise are poorly detected if we only consider f(Hb) (AUC = 0.64). Addition of the serum 6-miRNA signature to quantitative f(Hb) show high accuracy to detect patients with advanced colorectal neoplasia in average-risk individuals. A combination of these two non-invasive methods could be a good strategy to improve diagnostic performances of current CRC screening programmes.


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