Abstract
Recent proteomic studies identified Transferin (TF) as a potential colon cancer biomarker. A dipstick TF test similar to Immuno Fecal Occult Blood Test (IFOBT) was developed, and an initial study showed the TF test had compatible performance characteristics for detecting colon cancer and adenoma. The goal of this study was to evaluate the efficacy of the combination of TF and IFOBT for detecting advanced adenomas and cancer in asymptomatic and symptomatic populations. A total of 1,943 healthy subjects (asymptomatic group) and 201 subjects with various gastrointestinal symptoms (symptomatic group) were recruited for the study. For asymptomatic subjects, one fecal sample was collected for concurrent TF and IFOBT testing. Colonoscopy was performed for individuals positive for either TF or IFOBT. For the symptomatic subjects, each individual underwent TF, IFOBT, and colonoscopy simultaneously. For asymptomatic group, 1,737 individuals tested for TF and IFOBT, 251 subjects (14.5%) showed either TF or IFOBT positivity. Colonoscopy was performed for 193 of the 251 individuals. A total of 3 colorectal cancers and 43 advanced adenomas were detected. Combination of the two tests (either/or) significantly increased the detection rate for colorectal cancers and advanced adenomas compared to IFOBT alone (2.6% vs. 1.6%, P=0.034). In the symptomatic group, the combined test also significantly increased the sensitivity for detecting advanced adenomas and cancer than that of IFOBT alone (77.9% vs. 55.9%, P=0.006), but with decreased specificity (42.1% vs 63.9%, P=0.005). Combined TF and IFOBT test increased the detection rate of colorectal adenoma and cancer in both asymptomatic and symptomatic populations.
Highlights
The incidence of Colorectal Cancer (CRC) has increased rapidly in China and continues to be a major public health threat around the world
Immuno Fecal Occult Blood Test (IFOBT) was positive in 139 individuals (8.0%), while TF was positive in 184 individuals (10.6%), totaling up to 251 individuals (14.5%) who were positive for TF and/or IFOBT. Of these 251 individuals, 193 (76.9%) consented to receive colonoscopy; among them 43 individuals were found with advanced adenomas, and 3 individuals were diagnosed with colorectal cancer (1 in Dukes stage A and 2 in stage B)
IFOBTpositive subjects identified 2 carcinomas (2 in stage B) and 26 advanced adenomas for a 1.6% (28 of 1,737) detection rate, which was similar to the 1.8% (31 of 1,737) in TF-positive individuals with 2 carcinomas (1 in stage A and 1 in stage B) and 29 advanced adenomas
Summary
The incidence of Colorectal Cancer (CRC) has increased rapidly in China and continues to be a major public health threat around the world. In Beijing, the annual incidence of CRC increased from 16 to 24 per 100,000 in the past decade [1,2]. Especially the guaiac-based (gFOBT) test, is widely used in colorectal cancer screening and has been considered to be the preferred method in countries where medical resources are limited [3]. Antibody based Immuno Fecal Occult Blood Test (IFOBT) method improved the sensitivity, specificity, and cost-effectiveness of colorectal cancer screening [4,5,6], still about 20 to 40% colorectal cancers and 50 to 70% advanced adenomas may be missed with one-time IFOBT testing [5,6]
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