A multicentre clinical validation of AminoIndex Cancer Screening (AICS)

Haruo Mikami,Yohko Nakamura,Shinya Kikuchi,Minoru Yamakado,Osamu Kimura,Hiroshi Yamamoto,Toshihiko Ando

doi:10.1038/s41598-019-50304-y

Abstract

AminoIndex Cancer Screening (AICS) is a novel cancer screening test based on plasma free amino acid (PFAA) levels. This system categorises subjects as rank A, B, or C in order of increasing probability of each cancer incidence. The current study aimed to validate the potential of AICS for cancer detection. AICS values were determined from the PFAA levels in subjects examined at Chiba Cancer Center Cohort, Mitsui Memorial Hospital, and Saihaku Hospital, and the cancer incidence was investigated. The sensitivities of rank C for cancer diagnosis within 1 year after AICS examination were 83.3% (10/12) for gastric, 50.0% (2/4) for lung, 46.2% (6/13) for colorectal, 50.0% (8/16) for prostate, 43.8% (7/16) for breast, and 50.0% (1/2) for uterine/ovarian cancer. The total cancer detection rate via AICS was 0.33% (34/10,245). The sensitivities during the maximum follow-up period of 6.2 years were 51.7% (15/29) for gastric, 18.2% (2/11) for lung, 28.6% (8/28) for colorectal, 36.4% (8/22) for prostate, 29.0% (9/31) for breast, and 33.3% (2/6) for uterine/ovarian cancers. In conclusion, AICS is a more useful method for evaluating the probability of cancer incidence than for predicting onset, suggesting that annual AICS should be recommended to detect any malignancy.

Highlights

Cancer mortality has been constantly increasing in Japan, and cancer has been the leading cause of death since 19811
As for cancer screening, changes in plasma free amino acid (PFAA) profiles have been examined in various cancers and has led to the development of AminoIndex Cancer Screening (AICS) test
We validated the usefulness of AICS as a cancer screening tool through a large multicentre prospective study of 10,245 subjects in Japan

Summary

Introduction

Cancer mortality has been constantly increasing in Japan, and cancer has been the leading cause of death since 19811. The Japanese government distributes vouchers and provides free consultation services to encourage their citizens to undergo cancer screening. Despite these efforts, one of the current problems of cancer screening in Japan is a low medical examination rate because medical examinations for individual cancer types are time consuming and cause a physical burden. AICS was developed based on a multivariate analysis of PFAA concentrations compared with approximately 2,900 patients with various cancer and approximately 13,000 healthy controls through a case-control study. Because PFAA changes were similar in cervical, endometrial, and ovarian cancer, AICS(uterine/ovarian) was developed for comprehensive screening of these www.nature.com/scientificreports/. We aimed to validate the clinical usefulness of AICS for cancer detection

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