Utility of isocitrate dehydrogenase 1 as a serum protein biomarker for the early detection of non‐small‐cell lung cancer: A multicenter in vitro diagnostic clinical trial

We aimed to verify the expression status and diagnostic significance of isocitrate dehydrogenase 1 (IDH1) in non‐small‐cell lung cancer (NSCLC), especially during early stages. Serum IDH1 levels were measured by ELISA. A total of 1223 participants (660 patients with NSCLC, 276 healthy controls [HCs]...

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Veröffentlicht in:Cancer science 2020-05, Vol.111 (5), p.1739-1749
Hauptverfasser: Sun, Nan, Sun, Shouguo, Gao, Yibo, Li, Yuan, Lu, Zhiliang, Yuan, Zuyang, Che, Yun, Huang, Jianbing, Mao, Shuangshuang, Lei, Yuanyuan, Zang, Ruochuan, Li, Ning, Cui, Wei, Qi, Jun, Chen, Feng, Gao, Jia, Wang, Jinling, Min, Rong, Chen, Yan, Shi, Guangli, Tan, Fengwei, He, Jie
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container_end_page 1749
container_issue 5
container_start_page 1739
container_title Cancer science
container_volume 111
creator Sun, Nan
Sun, Shouguo
Gao, Yibo
Li, Yuan
Lu, Zhiliang
Yuan, Zuyang
Che, Yun
Huang, Jianbing
Mao, Shuangshuang
Lei, Yuanyuan
Zang, Ruochuan
Li, Ning
Cui, Wei
Qi, Jun
Chen, Feng
Gao, Jia
Wang, Jinling
Min, Rong
Chen, Yan
Shi, Guangli
Tan, Fengwei
He, Jie
description We aimed to verify the expression status and diagnostic significance of isocitrate dehydrogenase 1 (IDH1) in non‐small‐cell lung cancer (NSCLC), especially during early stages. Serum IDH1 levels were measured by ELISA. A total of 1223 participants (660 patients with NSCLC, 276 healthy controls [HCs], 95 patients with benign pulmonary conditions [BPCs], 135 patients with other cancers [OCs], and 57 samples with interfering factors) were divided into a training cohort and a validation cohort according to 3 testing centers. The IDH1 concentrations in the NSCLC group were obviously higher than those in the control groups (P 
doi_str_mv 10.1111/cas.14387
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Serum IDH1 levels were measured by ELISA. A total of 1223 participants (660 patients with NSCLC, 276 healthy controls [HCs], 95 patients with benign pulmonary conditions [BPCs], 135 patients with other cancers [OCs], and 57 samples with interfering factors) were divided into a training cohort and a validation cohort according to 3 testing centers. The IDH1 concentrations in the NSCLC group were obviously higher than those in the control groups (P &lt; .001). Area under the receiver operating characteristic curves (AUCs) for discriminating NSCLC patients from controls (HC, BPC, and OC) were 0.870 and 0.745 (sensitivity, 63.3% and 55.0%; specificity, 86.8% and 86.3%) in the training cohort and validation cohort, respectively. The AUCs for discriminating stage 0‐IA lung cancer patients from HCs were 0.907 and 0.788 (sensitivity, 58.6% and 59.1%; specificity, 92.9% and 89.3%) in 2 cohorts, respectively. Isocitrate dehydrogenase 1 showed specificity for NSCLC and had no diagnostic value for other common cancers. Furthermore, IDH1 was significantly reduced in postoperative serum. Isocitrate dehydrogenase 1 shows clinical utility as a serum protein biomarker for the early diagnosis of NSCLC. This is the first large‐scale study aiming to verify the level and diagnostic value of serum isocitrate dehydrogenase 1 (IDH1) in non‐small‐cell lung cancer (NSCLC) with well‐designed controls in multicenter‐based cohorts. IDH1 showed high diagnostic efficiency in early stage NSCLC and high specificity for NSCLC comparing to other cancers.</description><identifier>ISSN: 1347-9032</identifier><identifier>EISSN: 1349-7006</identifier><identifier>DOI: 10.1111/cas.14387</identifier><identifier>PMID: 32167618</identifier><language>eng</language><publisher>England: John Wiley &amp; Sons, Inc</publisher><subject>Biomarkers ; blood biomarker ; Cancer therapies ; Clinical trials ; Dehydrogenases ; diagnosis ; Disease ; early detection ; Enzymes ; Hospitals ; IDH1 ; Isocitrate dehydrogenase ; Lung cancer ; Medical prognosis ; Medical screening ; MicroRNAs ; Mortality ; Mutation ; Non-small cell lung carcinoma ; NSCLC ; Original ; Tomography ; Tumors</subject><ispartof>Cancer science, 2020-05, Vol.111 (5), p.1739-1749</ispartof><rights>2020 The Authors. published by John Wiley &amp; Sons Australia, Ltd on behalf of Japanese Cancer Association.</rights><rights>2020 The Authors. 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Serum IDH1 levels were measured by ELISA. A total of 1223 participants (660 patients with NSCLC, 276 healthy controls [HCs], 95 patients with benign pulmonary conditions [BPCs], 135 patients with other cancers [OCs], and 57 samples with interfering factors) were divided into a training cohort and a validation cohort according to 3 testing centers. The IDH1 concentrations in the NSCLC group were obviously higher than those in the control groups (P &lt; .001). Area under the receiver operating characteristic curves (AUCs) for discriminating NSCLC patients from controls (HC, BPC, and OC) were 0.870 and 0.745 (sensitivity, 63.3% and 55.0%; specificity, 86.8% and 86.3%) in the training cohort and validation cohort, respectively. The AUCs for discriminating stage 0‐IA lung cancer patients from HCs were 0.907 and 0.788 (sensitivity, 58.6% and 59.1%; specificity, 92.9% and 89.3%) in 2 cohorts, respectively. Isocitrate dehydrogenase 1 showed specificity for NSCLC and had no diagnostic value for other common cancers. Furthermore, IDH1 was significantly reduced in postoperative serum. Isocitrate dehydrogenase 1 shows clinical utility as a serum protein biomarker for the early diagnosis of NSCLC. This is the first large‐scale study aiming to verify the level and diagnostic value of serum isocitrate dehydrogenase 1 (IDH1) in non‐small‐cell lung cancer (NSCLC) with well‐designed controls in multicenter‐based cohorts. IDH1 showed high diagnostic efficiency in early stage NSCLC and high specificity for NSCLC comparing to other cancers.</abstract><cop>England</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>32167618</pmid><doi>10.1111/cas.14387</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-0285-5403</orcidid><orcidid>https://orcid.org/0000-0001-6799-5813</orcidid><oa>free_for_read</oa></addata></record>
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subjects Biomarkers
blood biomarker
Cancer therapies
Clinical trials
Dehydrogenases
diagnosis
Disease
early detection
Enzymes
Hospitals
IDH1
Isocitrate dehydrogenase
Lung cancer
Medical prognosis
Medical screening
MicroRNAs
Mortality
Mutation
Non-small cell lung carcinoma
NSCLC
Original
Tomography
Tumors
title Utility of isocitrate dehydrogenase 1 as a serum protein biomarker for the early detection of non‐small‐cell lung cancer: A multicenter in vitro diagnostic clinical trial
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