1.Ethical research of incentive policies for organ donation after citizen’s death
Xiaonan HU ; Renjie LYU ; Linying WANG ; Yexiang MENG ; Yu CUI ; Juan YAN
Organ Transplantation 2024;15(3):456-462
In recent years, with the rapid development of organ donation after citizen’s death and transplantation, central and local governments in China have successively released incentive policies. To protect the legitimate rights and interests of organ donors after citizen’s death and their families, current status of incentive policies for organ donation after citizen’s death was illustrated and analyzed from the perspective of ethics. Combining with the principles of justice, respect for autonomy, nonmaleficence and beneficence, the problems existing in the implementation of incentive policies for organ donation after citizen’s death were identified in China, such as lack of continuous psychological intervention in spiritual incentives, the misinterpretation of humanitarian assistance in practice and the impact of indirect economic incentives on individual donation autonomy, etc. Relevant countermeasures and suggestions were proposed at the government, society and individual levels, aiming to provide reference for improving the incentive policies for organ donation after citizen’s death and accelerate the development of organ donation in China.
2.Differentiating benign and malignant myxoid soft tissue tumors based on multiparametric MRI radiomics and deep learning models
Xiaonan YANG ; Dezhi WANG ; Chengjian WANG ; Dapeng HAO ; Wenjian XU ; Jiufa CUI
Chinese Journal of Medical Imaging Technology 2024;40(7):1078-1082
Objective To observe the value of multiparametric MRI-based radiomics model and deep learning(DL)model for distinguishing benign and malignant myxoid soft tissue tumors(MSTT).Methods A total of 141 MSTT patients confirmed with pathology were retrospectively collected.The patients were randomly divided into training set(n=98,including 51 cases of malignant MSTT and 47 cases of benign MSTT)and test set(n=43,including 22 cases of malignant MSTT and 21 cases of benign MSTT)at the ratio of 7∶3.Based on T1WI and fat suppression(FS)-T2WI in training set,radiomics features and DL features were extracted and selected,then a radiomics model and a DL model were constructed,respectively.Receiver operating characteristic(ROC)curves,calibration curves and decision curves were drawn,and the discrimination,calibration and net benefit of these 2 models were compared.Results In training set,the radiomics model for differentiating benign and malignant MSTT was constructed according to 9 optimal radiomics features,including 2 first order features,1 shape feature,3 gray level co-occurrence matrix features,1 gray level dependence matrix feature and 2 gray level size zone matrix features,while DL model was built based on 7 optimal DL features.In test set,the area under the ROC curve of radiomics model and DL model was 0.758 and 0.911,respectively,the latter was higher than the former(P=0.017).Both models had good calibration,and DL model had higher overall net benefit.Conclusion Compared with radiomics model,DL model based on MRI had better ability to differentiating benign and malignant MSTT,also higher overall net benefit.
3.Research advances in drug therapy for advanced primary liver cancer
Journal of Clinical Hepatology 2020;36(1):194-197
Liver cancer is one of the most common malignant tumors at present and has high incidence and mortality rates. Most patients are in the advanced stage at the time of diagnosis and thus lose the opportunity for surgery and have poor prognosis. At this time, medical treatment focusing on drug therapy becomes an important method for the treatment of advanced liver cancer, including chemotherapy, targeted therapy, immunotherapy, traditional Chinese medicine treatment, and endocrine therapy. This article reviews the recent research advances in drug therapy for advanced liver cancer.
4.Low-dose computed tomography screening for lung cancer in Tianjin: a preliminary clinical analysis of baseline screening and follow-up results
GAO ZHONGSONG ; YE ZHAOXIANG ; ZHANG PENG ; CUI XIAONAN ; XIE YONGSHENG ; HAN LIZHU
Chinese Journal of Clinical Oncology 2017;44(20):1034-1039
Objective:To explore the efficacy of low-dose computed tomography (LDCT) baseline and follow-up scans of lung cancer screening and to analyze lung nodules and other thoracic lesions detected from baseline and follow-up. Methods:A total of 650 sub-jects were enrolled in the LDCT lung cancer screening program, and investigators mainly focused on the analysis of 548 subjects who participated in the follow-up scan. The investigators recorded the nodules and other lesions of baseline screening, compared them with the follow-up images, and recorded their progress. Results:A total of 101 subjects were positive in the baseline screening, with a positivity rate of 18.4%. Six cases of lung cancer were confirmed by pathology, with a detection rate of 0.92%(6/650). The detection rate of lung cancer in female non-smokers (1.59%) was higher than that in male smokers (1.04%) without significant difference (P=0.624). Detected in the follow-up scan were 19 cases of new nodule-positive subjects. The positive rate for new nodules was 3.5%(19/548). The difference between the three-and two-dimensional levels was statistically significant. Conclusion:The effect of LDCT screen-ing for early lung cancer is significant. The detection rate in female non-smokers was not significantly higher than that in male smok-ers. Thus, LDCT lung cancer screening is equally significant for both sexes. The computer-aided detection (CAD) volume measurement technique is better to evaluate the progress of nodules during the follow-up interval.
5.Relation between lipid fluctuations of daily diet and insulin resistance in patients with type 2 diabetes mellitus with normal fasting lipid profile
Lijuan CUI ; Ling MA ; Yu HAN ; Liwei HUANG ; Yunhua YANG ; Xiaonan ZHANG ; Jing XU
Clinical Medicine of China 2016;32(7):615-618
Objective To investigate the relationship between lipid fluctuations of daily diet and insulin resistance in patients with type 2 diabetes mellitus(T2DM) with normal fasting lipid profile. Methods One hundred and ninety?eight cases patients with T2DM who were treated in the Endocrinology Department of the General Hospital of Benxi Iron and Steel Group Corporation from October 2012 to September 2014 were selected. Patients were divided into three groups according to fasting and postprandial 4 h triglyceride( TG4 h)
level,the group with normal fasting TG and normal TG4 h with 38 cases,the group with normal fasting TG and rising TG4 h with 78 cases,the group with rising fasting TG and rising TG4 h with 82 cases. The control group was composed of healthy volunteers with 20 cases. The patients followed daily diet habits to eat,blood glucose, insulin and lipid level of fasting and 2 h,4 h after lunch were monitored. Homeostasis model insulin resistance index( HOMA?IR) was used as an index to evaluate insulin resistance,and the correlation analysis was carried out with fasting and dietary intake of postprandial lipid metabolism. Results (1)HbA1c,FPG,HOMA?IR,TG and insulin level in the patients of the group with normal fasting TG and normal TG4 h,the group with normal fasting TG and rising TG4 h,the group with rising fasting TG and rising TG4 h were higher than the control group (HbA1c:(8. 4±1. 9)%,(8. 2±2. 4)%,(7. 8±1. 8)% vs. (4. 3±0. 6)%);FPG:(8. 98±1. 93) mmol/L, (8. 62±1. 33) mmol/L,(8. 28±1. 26) mmol/L vs. (4. 82±0. 63) mmol/L;,HOMA?IR:11. 07±0. 11,6. 98 ±0. 08,3. 83±0. 09 vs. 1. 24±0. 16;TG:0 h TG:(2. 35±1. 85) mmol/L,(1. 60±0. 41) mmol/L,(1. 58±0. 46) mmol/L vs. (0. 82±0. 25) mmol/L;2 h TG:(3. 97±2. 96) mmol/L,(2. 98±1. 49) mmol/L,(1. 83±0. 62) mmol/L vs. (1. 22±0. 31) mmol/L;4 h TG:(4. 24±1. 57) mmol/L,(3. 15±1. 63) mmol/L,(1. 92±0. 53) mmol/L vs. (1. 16±0. 24) mmol/L;insulin(0 h insulin:(26. 51±3. 65) mU/L,(18. 18±6. 24) mU/L,(10. 31 ±2. 38) mU/L vs. (5. 87±1. 62) mU/L;2 h insulin:(59. 15±8. 34) mU/L,(43. 75±9. 83) mU/L,(34. 27 ±1. 61) mU/L vs. (25. 24±1. 98) mU/L;4 h insulin:(51. 22±6. 79) mU/L,(40. 06±7. 51) mU/L,(31. 06 ±1.77) mU/L vs. (13.36±1.37) mU/L;P<0.05). (2)WHR(0.90±0.08 vs.0.72±0.06),HOMA?IR, insulin level of fasting and 2 h,4 h after lunch,TG of 2 h,4 h after lunch in the group with normal fasting TG and rising TG4 h were higher than the group with normal fasting TG and normal TG4 h ( P<0. 05 ) . ( 3 ) BMI ((27. 3±3. 3) kg/m2 vs. (23. 1±1. 5) kg/m2),WHR(0. 96±0. 10 vs. 0. 72±0. 06),HOMA?IR,TG and insulin level of fasting and 2 h,4 h after lunch in the group with rising fasting TG and rising TG4 h were higher than the group with normal fasting TG and normal TG4 h( P<0. 05) . HOMA?IR,TG and insulin level of fasting and 2 h, 4 h after lunch in the group with rising fasting TG and rising TG4 h were higher than the group with normal fasting TG and rising TG4 h( P<0. 05) . ( 4) HOMA?IR was positively correlated with BMI,WHR,and fasting TG levels in the groups with diabetes(r=0. 297,0. 376,0. 326,P<0. 05). HOMA?IR was significantly positively correlated with TG of 2 h,4 h after lunch in the groups with diabetes( r=0. 529,0. 693,P<0. 05) . HOMA?IR was significantly positively correlated with BMI and WHR in the control group(r=0. 617,0. 728,P <0. 05). HOMA?IR was not significantly correlated with fasting and postprandial TG in the control group. Conclusion Postprandial lipid metabolism disorder after daily diet is in some of patients with T2DM with normal fasting lipid profile. Postprandial lipid metabolism disorder after daily diet is significantly positively correlated with insulin resistance in patients with T2DM. Insulin resistance may be one of the pathogenesis of postprandial dyslipidemia in patients with type 2 diabetes.
6.Clinical value of multislice spiral computed tomography examination on risk assessment of gastrointestinal stromal tumor
Juxiang MA ; Zhaoxiang YE ; Xubin LI ; Houli LUO ; Xiaonan CUI ; Hongren WANG
Chinese Journal of Digestive Surgery 2015;14(3):242-247
Objective To summarize the features of multislice spiral computed tomography (MSCT) examination of gastrointestinal stromal tumors (GISTs),and investigate the relationship between predictors and risk of MSCT examination for GISTs.Methods The clinical data of 110 patients with GISTs who were admitted to the Tianjin Medical University Cancer Institute and Hospital from July 2011 to February 2014 were retrospectively analyzed.All the patients received 64-slices spiral CT (64S-SCT) or 16-slices spiral CT (16S-SCT) scan,and the data were transported to the PACS work station for multiplanar reconstruction.All the tumor samples were collected during operation and diagnosed by morphological manifestation and immunohistochemistry of tumors.Very low,low,and medium risk of GISTs were regarded as lower risk grade,and high risk of GISTs as high risk grade.The univariate analysis and multivariate analysis about features of imaging and risk were done by chi-square test and multivariate logistic regression model.Results Tumors located at the stomach in 81 cases,small intestines in 26 cases and colorectum in 3 cases.Diameter of tumors was 0.8-25.0 cm.Smaller tumors were in round or oval shape with well demarcated boundary,and larger tumors were irregular with unclear boundary.Endo-luminal growth of lessions was detected in 25 cases,duplex growth in 35 cases and extra-luminal growth in 50 cases.Enhanced CT scan showed that most of tumors in 105 patients demostrated moderate and high enhancement,heterogeneous enhancement in 74 cases,low density sacvariable necrosis area without enhancement in 60 cases and superficial,cracked-like and deep ulcer without calcification,metastasis and ascites in 23 cases.According to the features of GISTs by MSCT examination,location of tumor,diameter,shape,boundary,growth,enhancement,cystic necrosis,ulcer and metastasis were risk factors affecting risk classification of tumors by univariate analysis (x2=7.442,49.966,31.513,46.038,13.836,16.626,23.489,8.280,6.811,P <0.05).Diameter of tumor more than 10 cm and ulcer were independent risk factors affecting risk classification of tumors by multivariate analysis (OR =9.927,0.070 ; 95% confidence intewal:1.888-52.180,0.012-0.398,P < 0.05).Conclusion There is a characterization in the location,diameter,shape,boundary of tumor,growth,enhancement,cystic necrosis,ulcer and metastasis,and diameter of tumor more than 10cm and ulcer are independent risk factors affecting the risk classification of GISTs.
7.A standardized protocol for detection of ALK protein expression and gene fusion in lung adenocarcinoma cytologic specimens.
Zheng WANG ; Xiaonan WU ; Yuankai SHI ; Xiaohong HAN ; Gang CHENG ; Lin LI ; Xinlin MU ; Yuhui ZHANG ; Di CUI ; Li ZHANG ; Zaiwen FAN ; Guangqing ZHU ; Lingyun MA ; Li YANG ; Jing DI ; Dongge LIU
Chinese Journal of Oncology 2015;37(10):742-748
OBJECTIVEThe aim of this study was to establish a standardized protocol for detection of ALK protein expression and gene fusion in cytologic specimens.
METHODSLung adenocarcinoma cytologic specimens were collected from seven hospitals in Beijing city. A detection protocol for ALK protein expression and gene fusion was designed according to the results of comparative experiment. Ventana immunohistochemical (IHC) ALK(D5F3) detecting ALK protein expression was performed in 203 prepared formalin-fixed paraffin-embedded (FFPE) cell blocks. ALK gene fusion in 98 EGFR gene wild type cytologic specimens and in 4 bronchoalveolar lavage fluid (BL) samples was detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR). ALK gene fusion in the Ventana IHC ALK (D5F3) positive samples was further tested by fluorescence in situ hybridization (FISH). Six patients with ALK IHC-positive result were followed up to analyze the responses of crizotinib therapy. Comparative experiments: (1) Comparison of the results of 4% neutral buffered formalin fixed for different time (24 h, 48 h, 72 h) on the Ventana IHC ALK (D5F3) staining was conducted in two cases of IHC ALK positive FFPE cell blocks; (2) Comparing qRT-PCR results for ALK fusion in samples from FFPE cell blocks and cytospin prepared slides in 10 cases of lung adenocarcinoma cytologic specimens.
RESULTSAmong the specimens examined using the standardized protocol recommended by this study, 229 cases of cytologic specimens met the diagnostic criteria of lung adenocarcinoma. Among them, 207 cases obtained ALK gene test results (by at least one method), with an ALK test ratio of 90.4% (207/229). FFPE cell blocks were successfully prepared in 203 cases, Ventana IHC ALK (D5F3) were successfully performed in all the 203 FFPE cell blocks (100%), and the ALK protein positive detection rate was 10.3% (21/203). ALK fusion was tested in 98 FFPE cytologic samples of EGFR wild types by qRT-PCR, and 96 out of 98 (97.96%) cytologic samples were successfully performed.18 out of 19 IHC ALK-positive cases were verified to be of ALK fusion status by qRT-PCR. The concordance rate was 94.7% (Kappa=0.967, P<0.001) between Ventana IHC ALK (D5F3) and qRT-PCR, and the sensitivity of the Ventana IHC ALK (D5F3) assay compared with qRT-PCR was 100% and the specificity was 98.7%. FISH assay was used to verify the positive cases detected by Ventana IHC ALK (D5F3) staining. Two cases of low tumor cell content FFPE samples obtained indefinite results by FISH test. The six patients with positive ALK protein expression received crizotinib therapy, and 5 paitents got treated effectively. For two ALK IHC positive cases, which were 4% neutral buffered formalin fixed for 72 h, the result of Ventana IHC ALK (D5F3) staining became weakened obviously and uneven. In 10 cases of samples, total RNA was extracted from FFPE cytologic sections and cytospin prepared slides, and the results of qRT-PCR test and ALK gene fusion showed good concordance.
CONCLUSIONSThe standardized protocol recommended in this study expands the detection types and quantity of cytologic specimens for ALK protein expression and gene fusion and increased the detection rate. Ventana IHC ALK (D5F3) is a reliable method for detecting ALK protein expression in FFPE cell blocks. The pathologic quality control procedure prior to Ventana IHC ALK (D5F3) is crucial for the accuracy of testing the ALK gene status. When FFPE cell blocks could not be prepared or prepared unsuccessfully from the cytologic specimens, qRT-PCR may be an alternative option for the detection of ALK gene fusion.
Adenocarcinoma ; drug therapy ; enzymology ; genetics ; pathology ; Alkaline Phosphatase ; genetics ; metabolism ; Gene Fusion ; Genes, erbB-1 ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Lung Neoplasms ; drug therapy ; enzymology ; genetics ; pathology ; Protein Kinase Inhibitors ; therapeutic use ; Proteomics ; Pyrazoles ; therapeutic use ; Pyridines ; therapeutic use ; Sensitivity and Specificity
8.Establishment of biology reference interval of NSE in cerebrospinal fluid
Yanfei CAO ; Gang CHEN ; Lina ZHANG ; Xiupeng DONG ; Xiaonan KOU ; Ying CUI ; Xiuhua CAO
International Journal of Laboratory Medicine 2015;(10):1321-1322,1324
Objective To establish the reference intervals of neuron specific enolase (NSE) in tumor markers in cerebrospinal fluid .Methods According to National Committee for Clinical Laboratory Standards document C 28‐A2 ,120 samples were collected to establish reference intervals .Then ,the established intervals were evaluated according to China National Accreditation Service for Conformity Assessment document CL38 :2012 .Results The biological reference interval of NSE in cerebrospinal fluid was 0-3 .14 ng/mL .There was no significant correlation between cerebrospinal fluid NSE level and age ,sex (P> 0 .05) .Conclusion Method used in this study could be ensured reliable ,accurate ,scientific and practical ,desirable for clinical requirement and with great poten‐tial for clinical application .
9.A standardized protocol for detection of ALK protein expression and gene fusion in lung adenocarcinoma cytologic specimens
Zheng WANG ; Xiaonan WU ; Yuankai SHI ; Xiaohong HAN ; Gang CHENG ; Lin LI ; Xinlin MU ; Yuhui ZHANG ; Di CUI ; Li ZHANG ; Zaiwen FAN ; Guangqing ZHU ; Lingyun MA ; Li YANG ; Jing DI ; Dongge LIU
Chinese Journal of Oncology 2015;(10):742-748
Objective The aim of this study was to establish a standardized protocol for detection of ALK protein expression and gene fusion in cytologic specimens. Methods Lung adenocarcinoma cytologic specimens were collected from seven hospitals in Beijing city. A detection protocol for ALK protein expression and gene fusion was designed according to the results of comparative experiment. Ventana immunohistochemical ( IHC) ALK( D5F3) detecting ALK protein expression was performed in 203 prepared
formalin?fixed paraffin?embedded ( FFPE) cell blocks. ALK gene fusion in 98 EGFR gene wild type cytologic specimens and in 4 bronchoalveolar lavage fluid ( BL ) samples was detected by quantitative reverse transcription polymerase chain reaction (qRT?PCR). ALK gene fusion in the Ventana IHC ALK (D5F3) positive samples was further tested by fluorescence in situ hybridization ( FISH) . Six patients with ALK IHC?positive result were followed up to analyze the responses of crizotinib therapy. Comparative experiments:( 1) Comparison of the results of 4% neutral buffered formalin fixed for different time ( 24 h, 48 h, 72 h) on the Ventana IHC ALK (D5F3) staining was conducted in two cases of IHC ALK positive FFPE cell blocks;(2) Comparing qRT?PCR results for ALK fusion in samples from FFPE cell blocks and cytospin prepared slides in 10 cases of lung adenocarcinoma cytologic specimens. Results Among the specimens examined using the standardized protocol recommended by this study, 229 cases of cytologic specimens met the diagnostic criteria of lung adenocarcinoma. Among them, 207 cases obtained ALK gene test results ( by at least one method), with an ALK test ratio of 90.4% (207/229).FFPE cell blocks were successfully prepared in 203 cases, Ventana IHC ALK ( D5F3) were successfully performed in all the 203 FFPE cell blocks ( 100%) , and the ALK protein positive detection rate was 10.3% (21/203). ALK fusion was tested in 98 FFPE cytologic samples of EGFR wild types by qRT?PCR, and 96 out of 98 ( 97. 96%) cytologic samples were successfully performed.18 out of 19 IHC ALK?positive cases were verified to be of ALK fusion status by qRT?PCR. The concordance rate was 94.7% ( Kappa=0.967, P<0.001) between Ventana IHC ALK( D5F3) and qRT?PCR, and the sensitivity of the Ventana IHC ALK ( D5F3) assay compared with qRT?PCR was 100%and the specificity was 98. 7%. FISH assay was used to verify the positive cases detected by Ventana IHC ALK(D5F3) staining. Two cases of low tumor cell content FFPE samples obtained indefinite results by FISH test. The six patients with positive ALK protein expression received crizotinib therapy, and 5 paitents got treated effectively. For two ALK IHC positive cases, which were 4% neutral buffered formalin fixed for 72 h, the result of Ventana IHC ALK(D5F3) staining became weakened obviously and uneven. In 10 cases of samples, total RNA was extracted from FFPE cytologic sections and cytospin prepared slides, and the results of qRT?PCR test and ALK gene fusion showed good concordance. Conclusions The standardized protocol recommended in this study expands the detection types and quantity of cytologic specimens for ALK protein expression and gene fusion and increased the detection rate. Ventana IHC ALK( D5F3) is a reliable method for detecting ALK protein expression in FFPE cell blocks. The pathologic quality control procedure prior to Ventana IHC ALK( D5F3) is crucial for the accuracy of testing the ALK gene status. When FFPE cell blocks could not be prepared or prepared unsuccessfully from the cytologic specimens, qRT?PCR may be an alternative option for the detection of ALK gene fusion.
10.A standardized protocol for detection of ALK protein expression and gene fusion in lung adenocarcinoma cytologic specimens
Zheng WANG ; Xiaonan WU ; Yuankai SHI ; Xiaohong HAN ; Gang CHENG ; Lin LI ; Xinlin MU ; Yuhui ZHANG ; Di CUI ; Li ZHANG ; Zaiwen FAN ; Guangqing ZHU ; Lingyun MA ; Li YANG ; Jing DI ; Dongge LIU
Chinese Journal of Oncology 2015;(10):742-748
Objective The aim of this study was to establish a standardized protocol for detection of ALK protein expression and gene fusion in cytologic specimens. Methods Lung adenocarcinoma cytologic specimens were collected from seven hospitals in Beijing city. A detection protocol for ALK protein expression and gene fusion was designed according to the results of comparative experiment. Ventana immunohistochemical ( IHC) ALK( D5F3) detecting ALK protein expression was performed in 203 prepared
formalin?fixed paraffin?embedded ( FFPE) cell blocks. ALK gene fusion in 98 EGFR gene wild type cytologic specimens and in 4 bronchoalveolar lavage fluid ( BL ) samples was detected by quantitative reverse transcription polymerase chain reaction (qRT?PCR). ALK gene fusion in the Ventana IHC ALK (D5F3) positive samples was further tested by fluorescence in situ hybridization ( FISH) . Six patients with ALK IHC?positive result were followed up to analyze the responses of crizotinib therapy. Comparative experiments:( 1) Comparison of the results of 4% neutral buffered formalin fixed for different time ( 24 h, 48 h, 72 h) on the Ventana IHC ALK (D5F3) staining was conducted in two cases of IHC ALK positive FFPE cell blocks;(2) Comparing qRT?PCR results for ALK fusion in samples from FFPE cell blocks and cytospin prepared slides in 10 cases of lung adenocarcinoma cytologic specimens. Results Among the specimens examined using the standardized protocol recommended by this study, 229 cases of cytologic specimens met the diagnostic criteria of lung adenocarcinoma. Among them, 207 cases obtained ALK gene test results ( by at least one method), with an ALK test ratio of 90.4% (207/229).FFPE cell blocks were successfully prepared in 203 cases, Ventana IHC ALK ( D5F3) were successfully performed in all the 203 FFPE cell blocks ( 100%) , and the ALK protein positive detection rate was 10.3% (21/203). ALK fusion was tested in 98 FFPE cytologic samples of EGFR wild types by qRT?PCR, and 96 out of 98 ( 97. 96%) cytologic samples were successfully performed.18 out of 19 IHC ALK?positive cases were verified to be of ALK fusion status by qRT?PCR. The concordance rate was 94.7% ( Kappa=0.967, P<0.001) between Ventana IHC ALK( D5F3) and qRT?PCR, and the sensitivity of the Ventana IHC ALK ( D5F3) assay compared with qRT?PCR was 100%and the specificity was 98. 7%. FISH assay was used to verify the positive cases detected by Ventana IHC ALK(D5F3) staining. Two cases of low tumor cell content FFPE samples obtained indefinite results by FISH test. The six patients with positive ALK protein expression received crizotinib therapy, and 5 paitents got treated effectively. For two ALK IHC positive cases, which were 4% neutral buffered formalin fixed for 72 h, the result of Ventana IHC ALK(D5F3) staining became weakened obviously and uneven. In 10 cases of samples, total RNA was extracted from FFPE cytologic sections and cytospin prepared slides, and the results of qRT?PCR test and ALK gene fusion showed good concordance. Conclusions The standardized protocol recommended in this study expands the detection types and quantity of cytologic specimens for ALK protein expression and gene fusion and increased the detection rate. Ventana IHC ALK( D5F3) is a reliable method for detecting ALK protein expression in FFPE cell blocks. The pathologic quality control procedure prior to Ventana IHC ALK( D5F3) is crucial for the accuracy of testing the ALK gene status. When FFPE cell blocks could not be prepared or prepared unsuccessfully from the cytologic specimens, qRT?PCR may be an alternative option for the detection of ALK gene fusion.

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