scholarly journals Point Sensitivity of the Multi-target Stool DNA Test for Colorectal Cancer Screening in Individuals Ages 45-49 Years

2020 ◽  
Author(s):  
Michael Domanico ◽  
Sandra Statz ◽  
Emily Weiser ◽  
Barry M Berger ◽  
Paul J Limburg
Keyword(s):  
Colorectal Cancer ◽  
Precancerous Lesions ◽  
Screening Tests ◽  
Average Risk ◽  
Small Pilot Study ◽  
Data Annotation ◽  
Test Sensitivity ◽  
Link Type ◽  
Stool Samples ◽  
Stool Dna

Background: Most colorectal cancer (CRC) screening tests have not been rigorously studied in younger age groups. Aims: To estimate sensitivity of the multi-target stool DNA (mt-sDNA) test in patients ages 45-49 years. Methods: We identified archived stool samples (Exact Sciences; Madison, WI) from individuals ages 45-49 years who had completed an index colonoscopy and had confirmed diagnoses of CRC or advanced precancerous lesions (APL; defined as high-grade dysplasia, greater than 25% villous morphology, or greater than or equal to 1 cm in size [conventional adenoma or serrated lesion]). Data annotation referent to potential CRC risk factors, other than age, was limited. Stool samples were collected at least 7 days after the index colonoscopy, prior to lesion excision or treatment. Stool samples were processed and analyzed per established laboratory protocols for the mt-sDNA assay. Mt-sDNA test sensitivity for CRC, APL, and CRC+APL was estimated from the available sample set. Samples were collected from 2010-2013 (NCT01260168) and 2014-2017 (NCT02503631), with sample testing and analysis in 2019. Results: Stool samples were analyzed from 19 eligible subjects, 13 with CRC and 6 with APL. Estimated mt-sDNA test sensitivity for CRC, APL, and CRC+APL were 92%, 83%, and 89%, respectively. Conclusions: In this small pilot study using existing archived stool samples from subjects ages 45-49 years, mt-sDNA test sensitivity was similar to previously reported estimates for individuals ages greater than or equal to 50 years. These results support the application of mt-sDNA screening to average-risk patients beginning at age 45 years. Larger studies are needed to confirm and extend these findings.

scholarly journals Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening in a large, nationally insured cohort

2021 ◽  
Author(s):  
Lesley-Ann Miller-Wilson ◽  
Lila J Finney Rutten ◽  
Jack Van Thomme ◽  
A Burak Ozbay ◽  
Paul J Limburg
Keyword(s):  
Colorectal Cancer ◽  
National Sample ◽  
Adherence Rate ◽  
Average Risk ◽  
Cross Sectional ◽  
Commercial Insurance ◽  
Dna Test ◽  
Crc Screening ◽  
Stool Dna ◽  
Insured Patients

Abstract Purpose Colorectal cancer (CRC) is the second most deadly cancer in the USA. Early detection can improve CRC outcomes, but recent national screening rates (62%) remain below the 80% goal set by the National Colorectal Cancer Roundtable. Multiple options are endorsed for average-risk CRC screening, including the multi-target stool DNA (mt-sDNA) test. We evaluated cross-sectional mt-sDNA test completion in a population of commercially and Medicare-insured patients. Methods Participants included individuals ages 50 years and older with commercial insurance or Medicare, with a valid mt-sDNA test shipped by Exact Sciences Laboratories LLC between January 1, 2018, and December 31, 2018 (n = 1,420,460). In 2020, we analyzed cross-sectional adherence, as the percent of successfully completed tests within 365 days of shipment date. Results Overall cross-sectional adherence was 66.8%. Adherence was 72.1% in participants with Traditional Medicare, 69.1% in participants with Medicare Advantage, and 61.9% in participants with commercial insurance. Adherence increased with age: 60.8% for ages 50–64, 71.3% for ages 65–75, and 74.7% for ages 76 + years. Participants with mt-sDNA tests ordered by gastroenterologists had a higher adherence rate (78.3%) than those with orders by primary care clinicians (67.2%). Geographically, adherence rates were highest among highly rural patients (70.8%) and ordering providers in the Pacific region (71.4%). Conclusions Data from this large, national sample of insured patients demonstrate high cross-sectional adherence with the mt-sDNA test, supporting its role as an accepted, noninvasive option for average-risk CRC screening. Attributes of mt-sDNA screening, including home-based convenience and accompanying navigation support, likely contributed to high completion rates.

scholarly journals Colorectal Cancer Surveillance after Index Colonoscopy: Guidance from the Canadian Association of Gastroenterology

2013 ◽  
Vol 27 (4) ◽  
pp. 224-228 ◽  
Author(s):  
Desmond Leddin ◽  
Robert Enns ◽  
Robert Hilsden ◽  
Carlo A Fallone ◽  
Linda Rabeneck ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Task Force ◽  
Cancer Surveillance ◽  
Screening Tests ◽  
Average Risk ◽  
Health Care Environment ◽  
Canadian Association ◽  
The Us ◽  
Colonoscopy Surveillance

BACKGROUND: Differences between American (United States [US]) and European guidelines for colonoscopy surveillance may create confusion for the practicing clinician. Under- or overutilization of surveillance colonoscopy can impact patient care.METHODS: The Canadian Association of Gastroenterology (CAG) convened a working group (CAG-WG) to review available guidelines and provide unified guidance to Canadian clinicians regarding appropriate follow-up for colorectal cancer (CRC) surveillance after index colonoscopy. A literature search was conducted for relevant data that postdated the published guidelines.RESULTS: The CAG-WG chose the 2012 US Multi-Society Task Force (MSTF) on Colorectal Cancer to serve as the basis for the Canadian position, primarily because the US approach was the simplest and comprehensively addressed the issue of serrated polyps. Aspects of other guidelines were incorporated where relevant. The CAG-WG recommendations differed from the US MSTF guidelines in three main areas: patients with negative index colonoscopy should be followed-up at 10 years using any of the appropriate screening tests, including colonos-copy, for average-risk individuals; among patients with >10 adenomas, a one-year interval for subsequent colonoscopy is recommended; and for long-term follow-up, patients with low-risk adenomas on both the index and first follow-up procedures can undergo second follow-up colonos-copy at an interval of five to 10 years.DISCUSSION: The CAG-WG adapted the US MSTF guidelines for colonoscopy surveillance to the Canadian health care environment with a few modifications. It is anticipated that the present article will provide unified guidance that will enhance physician acceptance and encourage appropriate utilization of recommended surveillance intervals.

scholarly journals The CRCbiome study: a large prospective cohort study examining the role of lifestyle and the gut microbiome in colorectal cancer screening participants

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ane Sørlie Kværner ◽  
Einar Birkeland ◽  
Cecilie Bucher-Johannessen ◽  
Elina Vinberg ◽  
Jan Inge Nordby ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Screening ◽  
Gut Microbiome ◽  
Precancerous Lesions ◽  
Colorectal Carcinogenesis ◽  
Screening Tools ◽  
Screening Methods ◽  
Crc Screening ◽  
Link Type ◽  
Incidence And Mortality

Abstract Background Colorectal cancer (CRC) screening reduces CRC incidence and mortality. However, current screening methods are either hampered by invasiveness or suboptimal performance, limiting their effectiveness as primary screening methods. To aid in the development of a non-invasive screening test with improved sensitivity and specificity, we have initiated a prospective biomarker study (CRCbiome), nested within a large randomized CRC screening trial in Norway. We aim to develop a microbiome-based classification algorithm to identify advanced colorectal lesions in screening participants testing positive for an immunochemical fecal occult blood test (FIT). We will also examine interactions with host factors, diet, lifestyle and prescription drugs. The prospective nature of the study also enables the analysis of changes in the gut microbiome following the removal of precancerous lesions. Methods The CRCbiome study recruits participants enrolled in the Bowel Cancer Screening in Norway (BCSN) study, a randomized trial initiated in 2012 comparing once-only sigmoidoscopy to repeated biennial FIT, where women and men aged 50–74 years at study entry are invited to participate. Since 2017, participants randomized to FIT screening with a positive test result have been invited to join the CRCbiome study. Self-reported diet, lifestyle and demographic data are collected prior to colonoscopy after the positive FIT-test (baseline). Screening data, including colonoscopy findings are obtained from the BCSN database. Fecal samples for gut microbiome analyses are collected both before and 2 and 12 months after colonoscopy. Samples are analyzed using metagenome sequencing, with taxonomy profiles, and gene and pathway content as primary measures. CRCbiome data will also be linked to national registries to obtain information on prescription histories and cancer relevant outcomes occurring during the 10 year follow-up period. Discussion The CRCbiome study will increase our understanding of how the gut microbiome, in combination with lifestyle and environmental factors, influences the early stages of colorectal carcinogenesis. This knowledge will be crucial to develop microbiome-based screening tools for CRC. By evaluating biomarker performance in a screening setting, using samples from the target population, the generalizability of the findings to future screening cohorts is likely to be high. Trial registration ClinicalTrials.gov Identifier: NCT01538550.

scholarly journals Non-invasive colorectal cancer screening

2016 ◽  
Vol 85 (2) ◽  
pp. 29-31
Author(s):  
Melissa Holdren ◽  
Brittany Deller ◽  
Kevin Braden
Keyword(s):  
Colorectal Cancer ◽  
Developmental Process ◽  
Population Based ◽  
Adenomatous Polyps ◽  
Morbidity And Mortality ◽  
Screening Tests ◽  
Average Risk ◽  
Screening Programs ◽  
Asymptomatic Patients ◽  
Advanced Adenomas

Colorectal cancer (CRC) is a major cause of morbidity and mortality throughout the world and is the second most common cause of Canadian cancer-related deaths in men and the third most common in women. Most CRC appears to arise from the gradual development and advancement of colonic adenomatous polyps to cancerous tissue. This developmental process of CRC is the rationale for screening programs which aim to reduce CRC-related morbidity and mortality by early detection and removal of adenomatous polyps, specifically advanced adenomas. Although both the gFOBT and FIT function to detect occult bleeding in asymptomatic patients at average risk for CRC development, the mechanisms of these screening tests are distinct. gFOBT works by detecting the peroxidase activity of heme whereas FIT selectively detects human hemoglobin. The sensitivity in detecting CRC is higher for the FIT, with sensitivity of 0.79 compared to gFOBT with sensitivity of 0.36, they have similar specificities of 0.94 and 0.96, respectively. Currently, both the gFOBT and FIT are strongly recommended across Canada, with all provinces using the FIT, apart from Ontario and Manitoba which currently use the gFOBT to screen asymptomatic patients for CRC. A newer test, the sDNA test, identifies mutations in DNA that are shed by both adenomatous polyps and CRC cells. The sDNA test is more sensitive (0.92 95% CI 0.83-0.98) than both the gFOBT and FIT, however, is less specific and more expensive. Further data surrounding the sDNA test will be required prior to its implementation and recommendation for population based CRC screening in Canada. 

scholarly journals Comparing the Cost-Effectiveness of Innovative Colorectal Cancer Screening Tests

2020 ◽  
Author(s):  
Elisabeth F P Peterse ◽  
Reinier G S Meester ◽  
Lucie de Jonge ◽  
Amir-Houshang Omidvari ◽  
Fernando Alarid-Escudero ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Screening Tests ◽  
Computed Tomographic Colonography ◽  
Computed Tomographic ◽  
Colonoscopy Screening ◽  
Life Years ◽  
Stool Dna ◽  
The Cost

Abstract Background Colorectal cancer (CRC) screening with colonoscopy and the fecal immunochemical test (FIT) is underused. Innovative tests could increase screening acceptance. This study determined which of the available alternatives is most promising from a cost-effectiveness perspective. Methods The previously validated Microsimulation Screening Analysis-Colon model was used to evaluate the cost-effectiveness of screening with capsule endoscopy every 5 or 10 years, computed tomographic colonography every 5 years, the multi-target stool DNA test every 1 or 3 years, and the methylated SEPT9 DNA plasma assay (mSEPT9) every 1 or 2 years. We also compared these strategies with annual FIT screening and colonoscopy screening every 10 years. Quality-adjusted life-years gained (QALYG), number of colonoscopies, and incremental cost-effectiveness ratios were projected. We assumed a willingness-to-pay threshold of $100 000 per QALYG. Results Among the alternative tests, computed tomographic colonography every 5 years, annual mSEPT9, and annual multi-target stool DNA screening had incremental cost-effectiveness ratios of $1092, $63 253, and $214 974 per QALYG, respectively. Other screening strategies were more costly and less effective than (a combination of) these 3. Under the assumption of perfect adherence, annual mSEPT9 screening resulted in more QALYG, CRC cases averted, and CRC deaths averted than annual FIT screening but led to a high rate of colonoscopy referral (51% after 3 years, 69% after 5 years). The alternative tests were not cost-effective compared with FIT and colonoscopy. Conclusions This study suggests that for individuals not willing to participate in FIT or colonoscopy screening, mSEPT9 is the test of choice if the high colonoscopy referral rate is acceptable to them.

Preferences of Iranian average risk population for colorectal cancer screening tests

2019 ◽  
Vol 32 (4) ◽  
pp. 677-687
Author(s):  
Vajiheh Ramezani_Doroh ◽  
Alireza Delavari ◽  
Mehdi Yaseri ◽  
Sara Emamgholipour Sefiddashti ◽  
Ali Akbarisari
Keyword(s):  
Colorectal Cancer ◽  
Health Status ◽  
Discrete Choice ◽  
Choice Model ◽  
Screening Tests ◽  
Average Risk ◽  
Risk Population ◽  
Content Type ◽  
Crc Screening ◽  
Complication Risk

Purpose The purpose of this paper is to explore the preferences of the average risk Iranian population for colorectal cancer (CRC) screening tests. Design/methodology/approach A standard stated-preferences method with discrete choice models was used to identify the preferences. Data about socio-demographic status, health status and preferences for CRC screening tests were collected by a structured questionnaire that was completed by 500 people aged 50–75 years. Mixed logit model was used to analyze the preferences. Findings The regression model showed that the test process, pain, place, frequency, preparation, sensitivity, complication risk, mortality rate and cost were the final attributes; that had a statistically significant correlation with the preferences of the people in choosing CRC screening tests. The socio-demographic and health status of participants had no significant correlation with the individuals’ preferences. Practical implications This study provides insight into how different characteristics of a CRC screening test might influence the preferences of individuals about that test. Originality/value This was the first study of this type in Iran to elicit the preferences of the average risk population for CRC screening tests using a discrete choice model.

scholarly journals Current Tissue Molecular Markers in Colorectal Cancer: A Literature Review

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Gaia Peluso ◽  
Paola Incollingo ◽  
Armando Calogero ◽  
Vincenzo Tammaro ◽  
Niccolò Rupealta ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Risk Factors ◽  
Molecular Markers ◽  
Ct Colonography ◽  
Precancerous Lesions ◽  
Therapeutic Process ◽  
Cost Effective ◽  
Screening Tests ◽  
Endoscopic Evaluation ◽  
The World

Background. Colorectal cancer (CRC) is one of the most spread neoplasia types all around the world, especially in western areas. It evolves from precancerous lesions and adenomatous polyps, through successive genetic and epigenetic mutations. Numerous risk factors intervene in its development and they are either environmental or genetic.Aim of the Review. Alongside common screening techniques, such as fecal screening tests, endoscopic evaluation, and CT-colonography, we have identified the most important and useful biomarkers and we have analyzed their role in the diagnosis, prevention, and prognosis of CRC.Conclusion. Biomarkers can become an important tool in the diagnostic and therapeutic process for CRC. But further studies are needed to identify a noninvasive, cost-effective, and highly sensible and specific screening test for their detection and to standardize their use in clinical practice.

Fecal DNA Testing for Colorectal Cancer Screening

2020 ◽  
Vol 71 (1) ◽  
pp. 59-69 ◽  
Author(s):  
John M. Carethers
Keyword(s):  
Colorectal Cancer ◽  
Average Risk ◽  
Fecal Dna ◽  
Polyp Detection ◽  
Serrated Polyps ◽  
Crc Screening ◽  
Epigenetic Biomarkers ◽  
Life Years ◽  
Screening Strategies ◽  
Stool Dna

Fecal (or stool) DNA examination is a noninvasive strategy recommended by several medical professional societies for colorectal cancer (CRC) screening in average-risk individuals. Fecal DNA tests assay stool for human DNA shed principally from the colon. Colonic lesions such as adenomatous and serrated polyps and cancers exfoliate cells containing neoplastically altered DNA that may be detected by sensitive assays that target specific genetic and epigenetic biomarkers to discriminate neoplastic lesions from non-neoplastic tissue. Cross-sectional validation studies confirmed initial case-control studies’ assessment of performance of an optimized multitarget stool DNA (mt-sDNA) test, leading to approval by the US Food and Drug Administration in 2014. Compared to colonoscopy, mt-sDNA showed sensitivity of 92% for detection of CRC, much higher than the 74% sensitivity of another recommended noninvasive strategy, fecal immunochemical testing (FIT). Detections of advanced adenomas and sessile serrated polyps were higher with mt-sDNA than FIT (42% versus 24% and 42% versus 5%, respectively), but overall specificity for all lesions was lower (87% versus 95%). The mt-sDNA test increases patient life-years gained in CRC screening simulations, but its cost relative to other screening strategies needs to be reduced by 80–90% or its sensitivity for polyp detection enhanced to be cost effective. Noninvasive CRC screening strategies such as fecal DNA, however, have the potential to significantly increase national screening rates due to their noninvasive nature and convenience for patients.

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