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Novel Circulating Tumor Cell Assay for Detection of Colorectal Adenomas and Cancer.
Clinical and Translational Gastroenterology ( IF 3.0 ) Pub Date : 2019-10-01 , DOI: 10.14309/ctg.0000000000000088 Wen-Sy Tsai,Jeng-Fu You,Hsin-Yuan Hung,Pao-Shiu Hsieh,Ben Hsieh,Heinz-Josef Lenz,Gregory Idos,Shai Friedland,Jennifer Yi-Jiun Pan,Hung-Jen Shao,Jen-Chia Wu,Jr-Ming Lai,Shih-En Chang,Rui Mei,Drew Watson,Manana Javey,Ashish Nimgaonkar
Clinical and Translational Gastroenterology ( IF 3.0 ) Pub Date : 2019-10-01 , DOI: 10.14309/ctg.0000000000000088 Wen-Sy Tsai,Jeng-Fu You,Hsin-Yuan Hung,Pao-Shiu Hsieh,Ben Hsieh,Heinz-Josef Lenz,Gregory Idos,Shai Friedland,Jennifer Yi-Jiun Pan,Hung-Jen Shao,Jen-Chia Wu,Jr-Ming Lai,Shih-En Chang,Rui Mei,Drew Watson,Manana Javey,Ashish Nimgaonkar
OBJECTIVES
There is a significant unmet need for a blood test with adequate sensitivity to detect colorectal cancer (CRC) and adenomas. We describe a novel circulating tumor cell (CTC) platform to capture colorectal epithelial cells associated with CRC and adenomas.
METHODS
Blood was collected from 667 Taiwanese adults from 2012 to 2018 before a colonoscopy. The study population included healthy control subjects, patients with adenomas, and those with stage I-IV CRC. CTCs were isolated from the blood using the CellMax platform. The isolated cells were enumerated, and an algorithm was used to determine the likelihood of detecting adenoma or CRC. Nominal and ordinal logistic regression demonstrated that CTC counts could identify adenomas and CRC, including CRC stage.
RESULTS
The CellMax test demonstrated a significant association between CTC counts and worsening disease status (Cuzick's P value < 0.0001) with respect to the adenoma-carcinoma sequence. The test showed high specificity (86%) and sensitivity across all CRC stages (95%) and adenomatous lesions (79%). The area under the curve was 0.940 and 0.868 for the detection of CRC and adenomas, respectively.
DISCUSSION
The blood-based CTC platform demonstrated high sensitivity in detecting adenomas and CRC, as well as reasonable specificity in an enriched symptomatic patient population.
TRANSLATIONAL IMPACT
If these results are reproduced in an average risk population, this test has the potential to prevent CRC by improving patient compliance and detecting precancerous adenomas, eventually reducing CRC mortality.
更新日期：2019-11-01
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