A Quantitative Immunochemical Fecal Occult Blood Test for Colorectal Neoplasia

Levi, Zohar; Rozen, Paul; Hazazi, Rachel; Vilkin, Alex; Waked, Amal; Maoz, Eran; Birkenfeld, Shlomo; Leshno, Moshe; Niv, Yaron

doi:10.7326/0003-4819-146-4-200702200-00003

Cited by 290 publications

(274 citation statements)

References 30 publications

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“…15,23,30 In recent years, several published studies have analyzed FIT diagnostic accuracy in familial risk CRC screening, although none of them were specifically designed to assess it. [16][17][18][19]23,[30][31][32][33][34][35] Our study confirms previous data showing a high sensitivity and specificity for CRC at a 100 ng/ml positive threshold, reaching 100 and 90%, respectively. However, diagnostic accuracy for AN was lower in our study.…”

Section: Discussionmentioning

confidence: 99%

Fecal immunochemical test accuracy in familial risk colorectal cancer screening

Castro

Cubiella

Rivera

et al. 2013

Intl Journal of Cancer

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There is little information on fecal immunochemical test (FIT) in familial risk colorectal cancer (CRC) screening. Our study assesses FIT accuracy, number needed to scope (NNS) and cost to detect a CRC and an advanced neoplasia (AN) in this setting. We performed a multicentric, prospective, double-blind study of diagnostic tests on individuals with first-degree relatives (FDRs) with CRC submitted to screening colonoscopy. Two stool samples were collected and fecal hemoglobin in the first sample (FIT1) and the highest in both samples (FITmax) were determined. Areas under the curve (AUC) for CRC and AN as well as the best FIT1 and FITmax cutoff value for CRC were determined. At this threshold, NNS and the cost per lesion detected were calculated. A total of 595 individuals were included (one FDR > 60 years, 413; two FDR or one 60 years, 182). AN and CRC were found in 64 (10.8%) and six (1%) patients, respectively. For CRC diagnosis, FIT1 AUC was 0.96 [95% confidence interval (CI): 0.95-0.98] and FITmax AUC was 0.95 (95% CI: 0.93-0.97). For AN diagnosis, FIT1 and FITmax AUC were 0.74 (95% CI: 0.66-0.82). The best cutoff point for CRC was 115. At this threshold, the NNS to detect a CRC was 5.67 and 7.67, and the cost per CRC was 1,064e and 1591.33e on FIT1 and FITmax strategies, respectively. FIT shows high accuracy to detect CRC in familial CRC screening. Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.Colorectal cancer (CRC) is the third most common cancer worldwide and the second leading cause of cancer deaths in developed countries. 1 Several factors have been related to the risk of developing CRC. Age, sex and CRC familial history, especially if there are first-degree relatives (FDR) with CRC, are the strongest associated risk factors. 2 Furthermore, CRC risk is directly related to the number of FDRs and inversely related to the age of youngest FDRs. 3,4 Evidence on the best screening strategy in this population is limited and its quality is low. 5,6 At present, it is unclear which is the best screening strategy in individuals with a FDR with CRC. 7 Clinical practice guidelines recommend more aggressive screening than in average risk population, based on studies that have shown that endoscopic screening reduces CRC incidence and mortality in individuals with a FDR with CRC. 2,8 Screening is recommended from 40 years or 10 before the youngest proband. However, this approach has an empirical basis and no prospective controlled study has compared different screening strategies in this population. Furthermore, colonoscopy is an invasive technique that Key words: colorectal neoplasms, early detection of cancer, adenoma, occult blood, cost-benefit analysis Abbreviations: AN: advanced neoplasia; AUC: area under the curve; CI: confidence interval; CRC: colorectal cancer; FDR: first-degree relative; FIT: fecal immunochemical test; gFOBT: guaiac fecal occult blood tests; LLR: likelihood ratio; NNS: number needed to scope; NPV: negative predictive value; PPV: positi...

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Section: Discussionmentioning

confidence: 99%

Fecal immunochemical test accuracy in familial risk colorectal cancer screening

Castro

Cubiella

Rivera

et al. 2013

Intl Journal of Cancer

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“…While the fecal immunochemical test (FIT) is widely used in population-based screening for colorectal neoplasia and is effective in reducing colorectal cancer mortality through early detection, [1][2][3][4][5][6][7][8][9][10][11][12] it has been not yet known whether the detailed information on quantitative fecal hemoglobin concentration (FHbC) available with the FIT might also be of use for predicting the risk of colorectal neoplasia. Unfortunately, because clinical practice is to select subjects with FHbC greater than a set cut-off for further clinical investigation the precise value of FHbC, although measured and often reported, is largely neglected.…”

mentioning

confidence: 99%

A new insight into fecal hemoglobin concentration‐dependent predictor for colorectal neoplasia

Yen

Chen

Chiu

et al. 2014

Intl Journal of Cancer

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We sought to assess how much of the variation in incidence of colorectal neoplasia is explained by baseline fecal hemoglobin concentration (FHbC) and also to assess the additional predictive value of conventional risk factors. We enrolled subjects aged 40 years and over who attended screening for colorectal cancer with the fecal immunochemical test (FIT) in Keelung community-based integrated screening program. The accelerated failure time model was used to train the clinical weights of covariates in the prediction model. Datasets from two external communities were used for external validation. The area under curve (AUC) for the model containing only FHbC was 83.0% (95% CI: 81.5-84.4%), which was considerably greater than the one containing only conventional risk factors (65.8%, 95% CI: 64.2-67.4%). Adding conventional risk factors did not make significant additional contribution (p 5 0.62, AUC 5 83.5%, 95% CI: 82.1-84.9%) to the predictive model with FHbC only. Males showed a stronger linear dose-response relationship than females, yielding gender-specific FHbC predictive models. External validation confirms these results. The high predictive ability supported by a dose-dependent relationship between baseline FHbC and the risk of developing colorectal neoplasia suggests that FHbC may be useful for identifying cases requiring closer postdiagnosis clinical surveillance as well as being an early indicator of colorectal neoplasia risk in the general population. Our findings may also make contribution to the development of the FHbC-guided screening policy but its pros and cons in connection with cost and effectiveness of screening should be evaluated before it can be applied to population-based screening for colorectal cancer.While the fecal immunochemical test (FIT) is widely used in population-based screening for colorectal neoplasia and is effective in reducing colorectal cancer mortality through early detection, 1-12 it has been not yet known whether the detailed information on quantitative fecal hemoglobin concentration (FHbC) available with the FIT might also be of use for predicting the risk of colorectal neoplasia. Unfortunately, because clinical practice is to select subjects with FHbC greater than a set cut-off for further clinical investigation the precise value of FHbC, although measured and often reported, is largely neglected. The previous study reported that baseline FHbC can be predictive of incident colorectal neoplasia among screening participants who test negative at the first screen. 13 Nonetheless, it is not possible to fully investigate the relationship between risk of developing colorectal neoplasia and having a high FHbC because the natural history of the disease in those with FHbC levels above the cut off is interrupted owing to the administration of medical regime. To assess the predictive power of FHbC as a measure of risk of colorectal neoplasia one must develop a risk model based on FHbC (measured as a continuous variable at baseline in those testing both negative and positive according t...

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“…12,13,17,19,28,29 The sensitivity and specificity for CRC ranges from 53.3% to 94.1% and 87.5% to 96.9%, respectively. 18,28,30,31 The PPV ranges from 5.2% to 12.8% at a cut-off value of 75 ng/mL. 12,13,[17][18][19][28][29][30][31][32] The NNScreen and NNScope ranges from 213 to 936 and 12,13,17,19,[28][29][30]32 These results are summarised in Table 2.…”

Section: Immunochemical Faecal Occult Blood Testingmentioning

confidence: 68%

“…It is generally agreed that a cut-off of 75 ng/mL provides a balance between higher detection rate and lower NNScope. 12,15,18,21,22 It should also be noted though that different brands of iFOBT kits may yield different results even when the same cut-off is used.…”

Section: Immunochemical Faecal Occult Blood Testingmentioning

confidence: 99%