Dataset Information

Feasibility and performance of the fecal immunochemical test (FIT) for average-risk colorectal cancer screening in Nigeria.

ABSTRACT:

Introduction

There is a paucity of prospective data on the performance of the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening in sub-Saharan Africa. The aim of this exploratory analysis was to evaluate the feasibility and performance of FIT in Nigeria.

Methods

This was a prospective, single-arm study. A convenience sample of asymptomatic, average-risk individuals between 40-75 years of age were enrolled at Obafemi Awolowo University Teaching Hospital. Study participants returned in 48 hours with a specimen for ova and parasite (O&P) and qualitative FIT (50ug/g) testing. Participants with a positive FIT had follow-up colonoscopy and those with intestinal parasites were provided treatment.

Results

Between May-June 2019, 379 individuals enrolled with a median age of 51 years (IQR 46-58). In total, 87.6% (n = 332) returned for FIT testing. FIT positivity was 20.5% (95% CI = 16.3%-25.2%). Sixty-one (89.7%) of participants with a positive FIT had a follow-up colonoscopy (n = 61), of whom 9.8% (95%CI:3.7-20.2%) had an adenoma and 4.9% (95%CI:1.0-13.7%) had advanced adenomas. Presence of intestinal parasites was inversely related to FIT positivity (6.5% with vs. 21.1% without parasites, p = 0.05). Eighty-two percent of participants found the FIT easy to use and 100% would recommend the test to eligible family or friends if available.

Conclusions

Asymptomatic, FIT-based CRC screening was feasible and well tolerated in this exploratory analysis. However, the high FIT positivity and low positive predictive value for advanced neoplasia raises concerns about its practicality and cost effectiveness in a low-resource setting such as Nigeria.

SUBMITTER: Knapp GC

PROVIDER: S-EPMC7802943 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Feasibility and performance of the fecal immunochemical test (FIT) for average-risk colorectal cancer screening in Nigeria.

Knapp Gregory C GC Alatise Olusegun O Olopade Bolatito B Samson Marguerite M Olasehinde Olalekan O Wuraola Funmilola F Odujoko Oluwole O OO Komolafe Akinwunmi O AO Arije Olujide O OO Castle Philip E PE Smith J Joshua JJ Weiser Martin R MR Kingham T Peter TP

PloS one 20210112 1

<h4>Introduction</h4>There is a paucity of prospective data on the performance of the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening in sub-Saharan Africa. The aim of this exploratory analysis was to evaluate the feasibility and performance of FIT in Nigeria.<h4>Methods</h4>This was a prospective, single-arm study. A convenience sample of asymptomatic, average-risk individuals between 40-75 years of age were enrolled at Obafemi Awolowo University Teaching Hospital. Study p ...[more]

PMID: 33434195

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Project description:BackgroundThe estimated incidence of colorectal cancer is rising in Nigeria, where most patients present with advanced disease. Earlier detection of colorectal cancer is a goal of the Nigerian National Cancer Control Plan, but the utility of fecal-based screening is unclear. This study aimed to assess the fecal immunochemical test as a colorectal cancer screening modality in average-risk individualS in Nigeria.MethodsA population-based, cross-sectional study of qualitative fecal immunochemical test-based colorectal cancer screening was done in asymptomatic, average-risk participants aged 45-75 years in three states in Nigeria (Osun, Kwara, and Lagos). Participants were invited to enrol using age-stratified and sex-stratified convenience sampling following community outreach. Exclusion criteria included a personal history of colorectal cancer or rectal bleeding in the previous 6 months, a first-degree relative with a known diagnosis of colorectal cancer, or a comorbidity that would preclude conscious sedation or general anesthesia. Participants with positive fecal immunochemical test results underwent colonoscopy, and the positive predictive value of fecal immunochemical testing for colorectal cancer and advanced adenomas (≥10 mm, tubulovillous or villous or high-grade dysplasia) was calculated. Data on demographics and acceptability of fecal immunochemical testing and colonoscopy were collected.FindingsBetween January and April 2021, 2330 participants were enrolled in the study and received a fecal immunochemical test, which was returned by 2109 participants. 1677 participants tested negative and 432 tested positive. Of these 432 participants, 285 underwent a colonoscopy (235 showed no polyps or cancer, 47 had polyps identified, and three had colorectal cancer identified). Of the 47 participants who had polyps identified, 20 had advanced adenomas diagnosed. The median age was 57 years (IQR 50-63), 958 (41%) were male and 1372 (59%) were female, and 68% had at least a secondary-level education. Participants were evenly spread across wealth quintiles. The positivity rate of the fecal immunochemical test was 21% overall (432 of 2109; 95% CI 20-21%), 11% (51 of 455; 95% CI 10-12) in Lagos, 20% (215 of 1052; 95% CI 20-21) in Osun, and 28% (166 of 597; 95% CI 27-29) in Kwara. Among the patients with a positive fecal immunochemical test who completed colonoscopy, the positive predictive value for invasive colorectal cancer was 1·1% (95% CI 0·3-3·3), and 7·0% (4·5-10·8) for advanced adenoma. The acceptability of fecal immunochemical screening among participants was very high.InterpretationColorectal cancer screening with qualitative fecal immunochemical tests in Nigeria is feasible and acceptable to average-risk asymptomatic participants. However, the low positive predictive value for advanced neoplasia and high endoscopy burden investigating false positives suggests it might not be an appropriate screening tool in this setting.FundingThompson Family Foundation, Prevent Cancer Foundation, National Institutes of Health/National Cancer Institute Program Cancer Center.

Project description:BACKGROUND & AIMS:Biomarker assays could increase the accuracy of noninvasive detection of colorectal cancer (CRC); fecal immunochemical tests (FITs) are estimated to miss 27%-47% of CRCs and 70%-80% of advanced adenomas per round of screening. We investigated the conditions under which biomarker screens would be cost-effective compared with FIT screens of average-risk individuals. METHODS:We used the MISCAN-Colon microsimulation model to estimate the effects of various CRC screening test characteristics on life-years gained (LYG) and; age-specific all-cause mortality was based on the 2010 Dutch life tables. Simulated CRC incidence rate and CRC stage distribution were calibrated to observed data in The Netherlands from 1999 through 2003 (before opportunities for screening). Survival rates after diagnosis of CRC at an age younger than 75 years were based on CRC relative survival data from 1985 through 2004; survival for individuals diagnosed at an age of 75 years or older was adjusted to fit the observed age-increasing mortality/incidence ratio. We modeled FIT along with hypothetical biomarker tests with different test performance levels. For each biomarker test we calculated the maximum unit cost for the test to be cost-effective compared with FIT, assuming a willingness-to-pay threshold of €50,000 ($56,000) per LYG. RESULTS:Biennial FIT screening of subjects 55-75 years old provided 84.9 LYG at a cost of €122,000 ($137,000) per 1000 participants. Considering a unit cost of €7 ($8) for FIT (including kit and analysis only, excluding organizational costs), a biomarker test that detects CRC with higher levels of specificity and sensitivity (100%) and advanced adenomas at a proportionally higher level of sensitivity (53%) should never exceed a cost of €51 ($57). The threshold cost could increase to more than €200 ($224) for high-performing biomarker tests in cases of limited colonoscopy capacity or higher uptake of this test. CONCLUSIONS:By using the MISCAN-Colon microsimulation model to estimate effects of CRC screening tests, we found that for a biomarker test with increased overall performance to be cost-effective, it should not exceed 7-fold the unit cost of FIT. This maximum would increase substantially if colonoscopy becomes more expensive or scarce, or if the new test has higher screening uptake. These values could be used to estimate the added value of new biomarkers compared with current FIT screening.

Project description:BackgroundMany 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.MethodThe 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.DiscussionThe 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 registrationClinicaltrials.gov ; NCT05314309, registered April 6th 2022, first inclusions March 25th 2022 https://clinicaltrials.gov/ct2/results?cond=&term=NCT05314309&cntry=&state=&city=&dist =.

Dataset Information

Feasibility and performance of the fecal immunochemical test (FIT) for average-risk colorectal cancer screening in Nigeria.

Introduction

Methods

Results

Conclusions

Publications

Feasibility and performance of the fecal immunochemical test (FIT) for average-risk colorectal cancer screening in Nigeria.

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