FIT-based risk-stratification model effectively screens colorectal neoplasia and early-onset colorectal cancer in Chinese population: a nationwide multicenter prospective study

Abstract

No fully validated risk-stratification strategies have been established in China where colonoscopies resources are limited. We aimed to develop and validate a fecal immunochemical test (FIT)-based risk-stratification model for colorectal neoplasia (CN); 10,164 individuals were recruited from 175 centers nationwide and were randomly allocated to the derivation (n = 6776) or validation cohort (n = 3388). Multivariate logistic analyses were performed to develop the National Colorectal Polyp Care (NCPC) score, which formed the risk-stratification model along with FIT. The NCPC score was developed from eight independent predicting factors and divided into three levels: low risk (LR 0–14), intermediate risk (IR 15–17), and high risk (HR 18–28). Individuals with IR or HR of NCPC score or FIT+ were classified as increased-risk individuals in the risk-stratification model and were recommended for colonoscopy. The IR/HR of NCPC score showed a higher prevalence of CNs (21.8%/32.8% vs. 11.0%, P < 0.001) and ACNs (4.3%/9.2% vs. 2.0%, P < 0.001) than LR, which was also confirmed in the validation cohort. Similar relative risks and predictive performances were demonstrated between non-specific gastrointestinal symptoms (NSGS) and asymptomatic cohort. The risk-stratification model identified 73.5% CN, 82.6% ACN, and 93.6% CRC when guiding 52.7% individuals to receive colonoscopy and identified 55.8% early-onset ACNs and 72.7% early-onset CRCs with only 25.6% young individuals receiving colonoscopy. The risk-stratification model showed a good risk-stratification ability for CN and early-onset CRCs in Chinese population, including individuals with NSGS and young age.

Establishment and validation of symptomatic patients colorectal screening score for predicting colorectal neoplasia risk

“…48 Most patients visit hospitals due to minor GI symptoms without any alarm symptoms. 17 systemic symptoms, and history of aspirin use. 49 However, this score is too complex, which limits its clinical application.…”

“…We found that there was no significant difference in the incidence of CRN between symptomatic patients and asymptomatic individuals (23.3% vs 20.4%, P = 0.190), which is consistent with previous studies. 17 Previous studies have analyzed the diagnostic value of the combination of multiple symptoms for CRC, 15 and that the combination of symptoms defined by age has more diagnostic value than individual symptoms. 50 At present, studies mainly focused on the diagnostic value of rectal bleeding in symptomatic patients, but less on non-specific symptoms.…”

“…For example, in 2011 in the United Kingdom, over 65% of colonoscopies were used for diagnostic purposes, with only 10% used to screen average‐risk members of the general population 48 . Most patients visit hospitals due to minor GI symptoms without any alarm symptoms 17 . Symptomatic patients are more likely to undergo risk stratification of CRC compared to asymptomatic individuals.…”

“…15,16 The reason may be that GI symptoms are usually non-specific and can be influenced by factors such as diet and psychological conditions. Considering that limited colonoscopic resources are predominantly utilized in low-risk individuals with nonspecific gastrointestinal symptoms (NSGS), 17 in this study we aimed to establish a CRN risk scoring model for symptomatic individuals.…”

“…The diagnostic efficacy of our two newly established models was significantly better than that of other models. In addition, the model established by the variables selected through univariate logistic regression analysis achieved a higher sensitivity.Given that colonoscopy resources are primarily utilized by lowrisk individuals with NSGS,17 this study established the SPCS score to predict the risk of CRN in patients with non-specific symptoms. The SPCS score incorporates risk factors identified in previous studies, such as age, 7,51 sex, 7,51 smoking, 7,51 BMI,20,52 and family history of CRC,7,53 as well as a variable specific to symptomatic patients, namely, multiple symptoms.…”