Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population.

OBJECTIVE: An unmet need exists for a non-invasive biomarker assay to aid gastric cancer diagnosis. We aimed to develop a serum microRNA (miRNA) panel for identifying patients with all stages of gastric cancer from a high-risk population. DESIGN: We conducted a three-phase, multicentre study comprising 5248 subjects from Singapore and Korea. Biomarker discovery and verification phases were done through comprehensive serum miRNA profiling and multivariant analysis of 578 miRNA candidates in retrospective cohorts of 682 subjects. A clinical assay was developed and validated in a prospective cohort of 4566 symptomatic subjects who underwent endoscopy. Assay performance was confirmed with histological diagnosis and compared with Helicobacter pylori (HP) serology, serum pepsinogens (PGs), 'ABC' method, carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA19-9). Cost-effectiveness was analysed using a Markov decision model. RESULTS: We developed a clinical assay for detection of gastric cancer based on a 12-miRNA biomarker panel. The 12-miRNA panel had area under the curve (AUC)=0.93 (95% CI 0.90 to 0.95) and AUC=0.92 (95% CI 0.88 to 0.96) in the discovery and verification cohorts, respectively. In the prospective study, overall sensitivity was 87.0% (95% CI 79.4% to 92.5%) at specificity of 68.4% (95% CI 67.0% to 69.8%). AUC was 0.848 (95% CI 0.81 to 0.88), higher than HP serology (0.635), PG 1/2 ratio (0.641), PG index (0.576), ABC method (0.647), CEA (0.576) and CA19-9 (0.595). The number needed to screen is 489 annually. It is cost-effective for mass screening relative to current practice (incremental cost-effectiveness ratio=US$44 531/quality-of-life year). CONCLUSION: We developed and validated a serum 12-miRNA biomarker assay, which may be a cost-effective risk assessment for gastric cancer. TRIAL REGISTRATION NUMBER: This study is registered with ClinicalTrials.gov (Registration number: NCT04329299).

Bariatric/Metabolic Surgery in the Asia-Pacific Region: APMBSS 2018 Survey.

INTRODUCTION: The Asia-Pacific Metabolic and Bariatric Surgery Society (APMBSS) held its congress in Tokyo at the end of March, 2018, and representatives from Asia-Pacific countries presented the current status of bariatric/metabolic surgery in the "National Reports" session. The data are summarized here to show the current status and problems in the Asia-Pacific region in 2017. METHODS: A questionnaire including data of 2016 and 2017 and consisting of eight general questions was prepared and sent to representatives in 18 Asia-Pacific countries by e-mail before the congress. After the congress, the data were analyzed and summarized. RESULTS: Seventeen of 18 countries responded to the survey. The frequency of obesity (BMI ≥ 30) in the 4 Gulf countries was > 30%, much higher than that in the other countries. In total, 1640 surgeons and 869 institutions were engaging in bariatric/metabolic surgery. In many East and Southeast Asian countries, the indication for bariatric surgery was BMI ≥ 35 or ≥ 37, whereas in many Gulf countries and Australia, it was BMI ≥ 40 or ≥ 35 with obesity-related disease. Ten of the 17 countries (58.8%) but only one of the 5 Southeast Asian countries (20.0%) had public health insurance coverage for bariatric surgery. In 2017, 95,125 patients underwent bariatric/metabolic surgery, with sleeve gastrectomy accounting for 68.0%, bypass surgery for 19.5%, and others for 12.5%. Current problems included public insurance coverage, training system, national registry, and lack of awareness and comprehension. CONCLUSION: This summary showed that bariatric/metabolic surgery is rapidly developing along with various problems in Asia-Pacific countries.