microrna profiling of hepatocellular carcinomas in b6c3f1 mice treated with ginkgo biloba extract by...

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Tissue collec*on and miRNA extrac*on for miRNA array : Frozen samples from GBEinduced HCCs, spontaneous HCCs and vehicle control agematched normal livers from B6C3F1 mice from the 2year NTP bioassay were used for miRNA array analysis (n=5/group). miRNA extracPon was performed using mirVana miRNA IsolaPon Kit (Life technologies, Carlsbad, CA) and RNA integrity was measured with Bioanalyzer (Agilent Technologies, Santa Clara, CA). miRNA array hybridiza*on & data analysis : miRNA expression analysis was conducted using Affymetrix GeneChip ® miRNA 3.0 Array (Affymetrix, Santa Clara, CA) following manufacturer’s direcPons. miRNA expression data were normalized across all samples using the robust mulParray analysis (RMA) (Guo et al., 2010). RMAnormalized data were used for idenPfying differenPally expressed miRNAs using two pairwise analyses comparing GBE induced HCCs and spontaneous HCCs with vehicle control agematched normal livers from B6C3F1 mice. Using Ingenuity Pathway Analysis (IPA), we have analyzed the differenPally expressed miRNAs together with the corresponding transcriptomic data that we have previously obtained from these samples (Hoenerhoff et al., 2013). miRNA array data valida*on : QuanPtaPve RTPCR (QRTPCR) was used to validate miRNA array results. QRTPCR was performed using TaqMan ® MicroRNA Assay (Life technologies, Carlsbad, CA) on ABI PRISM 7900HT Sequence DetecPon System (Applied Biosystems, Foster City, CA). snoRNA202 was used as the endogenous control for normalizaPon of miRNA levels. miRNA expression analysis in livers from 90day GBE mouse study : miRNA was isolated and extracted from two 20 μm secPons of formalinfixed, paraffinembedded (FFPE) livers from control mice and from mice treated with 2000 mg/kg GBE for 90 days (n=6/group) with RecoverAll™ Total Nucleic Acid IsolaPon Kit for FFPE (Life technologies, Carlsbad, CA). QRTPCR was performed as described above. Ginkgo biloba leaf extract (GBE) has been used for centuries in tradiPonal Chinese medicine and today is used as an herbal supplement touted for improving neural funcPon and for its anPoxidant and anPcancer effects. Exposure of B6C3F1 mice to GBE in the 2year NaPonal Toxicology Program (NTP) bioassay resulted in a dosedependent increase in hepatocellular carcinomas (HCC). We have previously reported increased Ctnnb1 mutaPons and alteraPons in Wnt/Ctnnb1 signaling in GBEinduced HCC compared to spontaneous HCC in vehicle controls. MicroRNAs (miRNAs) are small non coding RNAs that are ogen dysregulated in various diseases including cancer. To idenPfy key miRNAs that modulate GBEinduced hepatocarcinogenesis, we examined global miRNA expression using Affymetrix GeneChip ® miRNA 3.0 arrays and two pairwise analyses (n=5/group) comparing GBEinduced HCCs and spontaneous HCCs with vehicle control agematched normal livers from B6C3F1 mice. Using a false discovery rate threshold of 5%, we observed 16 and 3 unique differenPally expressed miRNAs in GBEinduced HCC and spontaneous HCC, respecPvely. Ingenuity Pathway Analysis of the miRNA and mRNA array data from these tumors demonstrated altered molecular pathways associated with hepatocarcinogenesis, cell cycle progression, cell migraPon and cell proliferaPon. AddiPonally, miRs31, 145, 329 and 4333p, which were uniquely expressed in GBEinduced HCC, are known or predicted to regulate Wnt/Ctnnb1 signaling. In the miRNA expression analysis in livers from the 90day GBE mouse study, miRs411, 300, 127 and 134 were upregulated more than double in GBEtreated group compared to vehicle control group, indicaPng that these miRNAs could serve as potenPal biomarkers for GBE exposure or hepatocellular carcinogenesis. Abstract It has become increasingly apparent that epigenePc mechanisms are at play in the mechanisms of carcinogenesis. MicroRNAs (miRNAs) have been idenPfied as a new layer of gene regulatory mechanisms (Lujambio and Lowe, 2012). The importance of miRNAs in cancer is highlighted by the observaPon that half of the known aberrant expressions of miRNAs are located in cancer associated genomic regions (Wiklund et al., 2010). On the relaPonship between miRNAs and hepatocellular carcinoma (HCC) in humans, several studies have detected the aberrant expression of specific miRNAs in malignant HCC, compared to normal hepatocyte (Masaki, 2009). There is widespread and unregulated use of GBE as a dietary supplement by the American public, and thus is a significant public health concern. NTP’s Ginkgo biloba leaf extract (GBE) bioassay has indicated that chronic GBE exposure to B6C3F1 mouse resulted in a dose dependent increase in hepatocarcinogenicity. Recent transcriptomic studies on GBEinduced HCC indicated dysregulated cancer gene expression. In AddiPon, increased Ctnnb1 mutaPons and alteraPons in Wnt/Ctnnb1 signaling were demonstrated in GBEinduced HCC compared to spontaneous HCC (Hoenerhoff et al., 2013). Determining the mechanisms of GBEinduced hepatocarcinogenicity in rodents may aid in assessing the health risks of human exposure. We hypothesize that genePc and epigenePc pathways dysregulated in GBEinduced mouse HCC may reflect key pathways altered in human HCC. The objecPve of this study is to characterize the pamern of dysregulated miRNAs occurring in spontaneous and GBEinduced HCC and compare it to the corresponding mRNA alteraPons in HCC. In the NTP 2year mouse GBE bioassay, there was a dose dependent increase in HCC (NTP TR 578, Table 1). Using the Affymetrix GeneChip ® miRNA 3.0 Array plaoorm, when compared to normal livers, there were 3 and 16 unique differenPally expressed mouse miRNAs in spontaneous HCC and GBEinduced HCC, respecPvely, at FDR ≤ 0.05 (Figure 1 and 2, Table 2). Analyzing miRNA and the corresponding mRNA array data in IPA, we have found several differenPally altered molecular pathways associated with HCC development in both GBE induced HCCs and spontaneous HCCs (Tables 3, 4, and 5). Therefore, these data show that GBEinduced HCCs are disPnguishable from spontaneous HCC in terms of their miRNA expression profile. We have previously reported increased Ctnnb1 mutaPons and alteraPons in Wnt/Ctnnb1 signaling in GBEinduced HCC compared to spontaneous HCC in vehicle controls. In addiPon, in GBEinduced HCC, there was cytoplasmic accumulaPon of CTNNB1 and loss of normal CDH1 membrane immunoreacPvity, with accumulaPon of the protein in the cytoplasm that suggests disrupPon of CTNNB1/CDH1 complexes within adherens juncPons, which is associated with a more malignant phenotype (Hoenerhoff et al., 2013). In this study, we found 4 miRNAs that were uniquely expressed in GBE induced HCC and known or predicted to regulate Wnt/Ctnnb1 signaling (Table 5). One of them, miR31 was strongly downregulated (83fold by QRTPCR) in GBEinduced HCC with no change in spontaneous HCC compared to normal livers and predicted to regulate Cdk1, which was upregurated in GBE induced HCC. CDK1 plays a key role in cell cycle regulaPon and increases Src kinase acPvity (Roskoski, 2005). PhosphorylaPon by Src kinase disrupts binding of CTNNB1/CDH1 and results in loss of the complexes from the cell surface (Nelson and Nusse, 2004). Therefore, miR31 seems to indirectly modulate Wnt/Ctnnb1 signaling in GBEinduced HCC. However, further studies are needed to evaluate the effect of miR31 on Wnt/Ctnnb1 signaling. In order to determine if there are any miRNAs that could potenPally serve as a biomarker for GBE exposure and/or early biomarkers of hepatocellular carcinogenesis, we have also analyzed the miRNA expression in livers from the 90day GBE mouse study. The expression of miRs411, 300, 127 and 134 more than doubled in GBEtreated group compared to vehicle control group (Figure 3). In the 90day GBE study, although hepatocellular hypertrophy and focal necrosis were found in the livers, there were no preneoplasPc hepaPc foci (NTP TR 578, Table 1). Since these miRNAs were uniquely expressed in livers from 90day exposures and in HCCs from GBE exposure or arising spontaneously, they could serve as potenPal biomarkers for GBE exposure or hepatocellular carcinogenesis. These results suggest that these miRNAs might be useful as biomarkers of exposure and apical endpoints. However, further validaPons in prospecPve studies are necessary in order to validate these findings. In addiPon, although this QRTPCR analysis was performed using miRNA extracted from secPons of FFPE livers, all the miRNAs analyzed were amplified with relaPve ease, indicaPng that archival FFPE Pssues can be leveraged for miRNAbased biomarker idenPficaPon. Introduc.on Materials and Methods Result and Discussion Results MicroRNA Profiling of Hepatocellular Carcinomas in B6C3F1 Mice Treated with Ginkgo biloba Extract by gavage Yamashita H 1,2 , Pandiri AR 1,3 , Bhusari S 1 , Shockley KR 4 , Peddada SD 4 , Gerrish KE 5 , Rider CV 1 , Hoenerhoff MJ 1 , Sills RC 1 . 1 Cellular & Molecular Pathology Branch, NaPonal Toxicology Program, NaPonal InsPtute of Environmental Health Sciences (NIEHS), Research Triangle Park, NC, United States, 2 Taisho PharmaceuPcal Co. Ltd., Saitama, Japan, 3 Experimental Pathology Laboratories, Research Triangle Park, NC, United States, 4 BiostaPsPcs Branch, NIEHS, Research Triangle Park, NC, United States, 5 Molecular Genomics Core Laboratory, NIEHS, Research Triangle Park, NC, United States. Table 1. Incidences of select hepaPc lesions in B6C3F1 mice treated with Ginkgo biloba leaf extract (GBE) by gavage in subchronic (90day) and chronic (2year) NaPonal Toxicology Program studies (NTP TR 578). Figure 1. (A) Principal component analysis (PCA) of global miRNA expression profiles demonstrated nearly disPnct clustering of normal liver (blue), spontaneous HCC (green) and GBEinduced HCC (red) samples. (B) Using a false discovery rate threshold of 5%, 3 and 16 unique mouse miRNAs were differenPally expressed in spontaneous HCC and GBEinduced HCC, respecPvely. The number in the parenthesis indicates the number of differenPally expressed miRNAs from other species besides mice. We would like to thank DNTP and DIR, NIEHS for funding this project. We would also like to thank the NIEHS Microarray core and the Histology core Laboratory in the Cellular and Molecular Pathology Branch for their technical assistance on this project. Acknowledgements Table 2 Table 2. DifferenPally expressed miRNAs and their target genes in spontaneous and GBEinduced HCC compared to agematched normal livers. Table 3 Table 3. RepresentaPve altered miRNAmRNA interacPons and molecular pathways. Ingenuity Pathway Analysis of target mRNAs of differenPally altered miRNAs in spontaneous and GBEinduced HCC demonstrated dysregulated molecular pathways associated with hepatocarcinogenesis, cell cycle progression, cell migraPon and cell proliferaPon. Table 4. DifferenPally altered miRNAs from other species that are staPsPcally significant (but not in mice) and that play a role in human hepatocellular carcinogenesis. These miRNA sequences are typically conserved across species and are likely to be relevant even in mouse hepatocellular carcinogenesis. Table 5 Table 5. miRs329, 31, 145 and 4333p, which were uniquely expressed in GBEinduced HCC, are known or predicted to regulate Wnt/Ctnnb1 signaling. Figure 2. QuanPtaPve RTPCR validaPon of miRNA array expression changes observed in spontaneous HCC and GBEinduced HCC normalized to normal livers. Figure 3. QuanPtaPve RTPCR of miRNAs in livers from B6C3F1 mice treated with 2000 mg/kg GBE for 90 days. The miRNA expression in GBE livers was normalized to normal livers. 1. Lujambio A, Lowe SW. 2012. The microcosmos of cancer. 482(7385):34755. 2. Wiklund ED, Kjems J, Clark SJ. 2010. EpigenePc architecture and miRNA: reciprocal regulators. Epigenomics. 2(6):82340. 3. Masaki T. 2009. MicroRNA and hepatocellular carcinoma. Hepatol Res. 39(8):7512. 4. Hoenerhoff MJ, Pandiri AR, Snyder SA, et al. 2013. Hepatocellular carcinomas in B6C3F1 mice treated with Ginkgo biloba extract for two years differ from spontaneous liver tumors in cancer gene mutaPons and genomic pathways. Toxicol Pathol. 41(6):82641. 5. Guo W, Sarkar SK, Peddada SD. 2010. Controlling false discoveries in mulPdimensional direcPonal decisions, with applicaPons to gene expression data on ordered categories. Biometrics. 66(2):48592. 6. NTP TR 578. 2013. NTP technical report on the toxicology and carcinogenesis studies of Ginkgo Biloba Extract (CAS NO. 90045366) in F344/N rats and B6C3F1/N mice (Gavage studies) 7. Li J, Fu H, Xu C, et al. 2010. miR183 inhibits TGFbeta1induced apoptosis by downregulaPon of PDCD4 expression in human hepatocellular carcinoma cells. BMC Cancer. 10:354. 8. Ura S, Honda M, Yamashita T, et al. 2009. DifferenPal microRNA expression between hepaPPs B and hepaPPs C leading disease progression to hepatocellular carcinoma. Hepatology. 49(4):1098112. 9. Sun X, He Y, Huang C, Ma TT, et al. 2013. DisPncPve microRNA signature associated of neoplasms with the Wnt/βcatenin signaling pathway. Cell Signal. 25(12):280511. 10. Toffanin S, Hoshida Y, Lachenmayer A, et al. 2011. MicroRNAbased classificaPon of hepatocellular carcinoma and oncogenic role of miR517a. Gastroenterology. 2011. 140(5):161828. 11. Law PT, Ching AK, Chan AW, et al. 2012. MiR145 modulates mulPple components of the insulinlike growth factor pathway in hepatocellular carcinoma. Carcinogenesis. 33(6):113441. 12. Sachdeva M, Mo YY. 2010. MicroRNA145 suppresses cell invasion and metastasis by directly targePng mucin 1. Cancer Res. 70(1):37887. 13. Kim SJ, Oh JS, Shin JY, et al. 2011. Development of microRNA145 for therapeuPc applicaPon in breast cancer. J Control Release. 155(3):42734. 14. Roskoski R Jr. 2005. Src kinase regulaPon by phosphorylaPon and dephosphorylaPon. Biochem Biophys Res Commun. 331(1):114. 15. Nelson WJ, Nusse R. 2004. Convergence of Wnt, betacatenin, and cadherin pathways. Science. 303(5663):14837. References GBEinduced mouse HCCs are markedly different from spontaneous HCCs in terms of their global miRNA expression profile. The miRNA and mRNA array data from these tumors demonstrated altered molecular pathways associated with hepatocellular carcinogenesis. miRs31, 145, 329 and 433 that were uniquely expressed in GBEinduced HCC are known or predicted to regulate Wnt/Ctnnb1 signaling. miRs411, 300, 127 and 134 were upregulated in the livers from GBE treated group compared to vehicle control group from 90day GBE mouse study and these miRNAs could serve as potenPal biomarkers for GBE exposure or hepatocellular carcinogenesis. Conclusions (B) a10 male and female B6C3F1 mice were exposed to 0, 125, 250, 500, 1,000, and 2,000 mg/kg GBE by gavage, once daily, 5 days per week for 90 days. bSeverity grade based on 0–4 grading scale (0 = no significant lesion, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). c 50 male and female B6C3F1 mice were exposed to 0, 200, 600, and 2,000mg/kg GBE by gavage, once daily, 5 days per week for two years. dStaPsPcal analysis not available for metastaPc lesions. Significantly different from controls *p < .05, **p < .01 by the poly3 test. #1 Target genes that showed relaPonship with the respecPve miRNA in IPA analysis (experimentally observed or predicted) and down or upregulated in GBEinduced HCC microarray analysis. #2 No informaPon on the target genes was found in IPA knowledge base on these miRNAs. Figure 3 Figure 1 Figure 2 #1 Target genes that showed relaPonship with the respecPve miRNA in IPA analysis (experimentally observed or predicted) and down or upregulated in GBEinduced HCC microarray analysis. : Known to decrease the diseases or funcPon and is downregulated in the dataset. : Known to increase the diseases or funcPon and is upregulated in the dataset. : Literature indicates this gene is involved in the diseases or funcPon but does not indicate whether it increases or decreases it. And the gene is down or upregulated in the dataset. Table 4 Table 1 (A) GBEinduced HCC Spontaneous HCC Normal liver

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Page 1: MicroRNA Profiling of Hepatocellular Carcinomas in B6C3F1 Mice Treated with Ginkgo biloba Extract by Gavage for 2 Years

 

 

Tissue  collec*on  and  miRNA  extrac*on  for  miRNA  array:  Frozen  samples  from  GBE-­‐induced  HCCs,  spontaneous  HCCs  and  vehicle  control  age-­‐matched  normal  livers  from  B6C3F1  mice  from  the  2-­‐year  NTP  bioassay  were  used  for  miRNA  array  analysis  (n=5/group).  miRNA  extracPon  was  performed  using  mirVana  miRNA  IsolaPon  Kit  (Life  technologies,  Carlsbad,  CA)  and  RNA  integrity  was  measured  with  Bioanalyzer  (Agilent  Technologies,  Santa  Clara,  CA). miRNA  array  hybridiza*on  &  data  analysis:  miRNA  expression  analysis  was  conducted  using  Affymetrix  GeneChip®  miRNA  3.0  Array  (Affymetrix,  Santa  Clara,  CA)  following  manufacturer’s  direcPons.  miRNA  expression  data  were  normalized  across  all  samples  using  the  robust  mulParray  analysis  (RMA)  (Guo  et  al.,  2010).  RMA-­‐normalized  data  were  used  for  idenPfying  differenPally  expressed  miRNAs  using  two  pairwise  analyses  comparing  GBE-­‐induced  HCCs  and  spontaneous  HCCs  with  vehicle  control  age-­‐matched  normal  livers  from  B6C3F1  mice.  Using  Ingenuity  Pathway  Analysis  (IPA),  we  have  analyzed  the  differenPally  expressed  miRNAs  together  with  the  corresponding  transcriptomic  data  that  we  have  previously  obtained  from  these  samples  (Hoenerhoff  et  al.,  2013). miRNA  array  data  valida*on:  QuanPtaPve  RT-­‐PCR  (QRT-­‐PCR)  was  used  to  validate  miRNA  array  results.  QRT-­‐PCR  was  performed  using  TaqMan®  MicroRNA  Assay  (Life  technologies,  Carlsbad,  CA)  on  ABI  PRISM  7900HT  Sequence  DetecPon  System  (Applied  Biosystems,  Foster  City,  CA).  snoRNA202  was  used  as  the  endogenous  control  for  normalizaPon  of  miRNA  levels. miRNA  expression  analysis  in  livers  from  90-­‐day  GBE  mouse  study:  miRNA  was  isolated  and  extracted  from  two  20  μm  secPons  of  formalin-­‐fixed,  paraffin-­‐embedded  (FFPE)  livers  from  control  mice  and  from  mice  treated  with  2000  mg/kg  GBE  for  90  days  (n=6/group)  with  RecoverAll™  Total  Nucleic  Acid  IsolaPon  Kit  for  FFPE  (Life  technologies,  Carlsbad,  CA).  QRT-­‐PCR  was  performed  as  described  above.    

 

Ginkgo  biloba  leaf  extract  (GBE)  has  been  used  for  centuries  in  tradiPonal  Chinese  medicine  and  today  is  used  as  an  herbal  supplement  touted  for  improving  neural  funcPon  and  for  its  anPoxidant  and  anPcancer  effects.  Exposure  of  B6C3F1  mice  to  GBE  in  the  2-­‐year  NaPonal  Toxicology  Program  (NTP)  bioassay  resulted  in  a  dose-­‐dependent  increase  in  hepatocellular  carcinomas  (HCC).  We  have  previously  reported  increased  Ctnnb1  mutaPons  and  alteraPons  in  Wnt/Ctnnb1  signaling  in  GBE-­‐induced  HCC  compared  to  spontaneous  HCC  in  vehicle  controls.  MicroRNAs  (miRNAs)  are  small  non-­‐coding  RNAs  that  are  ogen  dysregulated  in  various  diseases  including  cancer.  To  idenPfy  key  miRNAs  that  modulate  GBE-­‐induced  hepatocarcinogenesis,  we  examined  global  miRNA  expression  using  Affymetrix  GeneChip®  miRNA  3.0  arrays  and  two  pairwise  analyses  (n=5/group)  comparing  GBE-­‐induced  HCCs  and  spontaneous  HCCs  with  vehicle  control  age-­‐matched  normal  livers  from  B6C3F1  mice.  Using  a  false  discovery  rate  threshold  of  5%,  we  observed  16  and  3  unique  differenPally  expressed  miRNAs  in  GBE-­‐induced  HCC  and  spontaneous  HCC,  respecPvely.  Ingenuity  Pathway  Analysis  of  the  miRNA  and  mRNA  array  data  from  these  tumors  demonstrated  altered  molecular  pathways  associated  with  hepatocarcinogenesis,  cell  cycle  progression,  cell  migraPon  and  cell  proliferaPon.  AddiPonally,  miRs-­‐31,  145,  329  and  433-­‐3p,  which  were  uniquely  expressed  in  GBE-­‐induced  HCC,  are  known  or  predicted  to  regulate  Wnt/Ctnnb1  signaling.    In  the  miRNA  expression  analysis  in  livers  from  the  90-­‐day  GBE  mouse  study,  miRs-­‐411,  300,  127  and  134  were  upregulated  more  than  double  in  GBE-­‐treated  group  compared  to  vehicle  control  group,  indicaPng  that  these  miRNAs  could  serve  as  potenPal  biomarkers  for  GBE  exposure  or  hepatocellular  carcinogenesis.    

Abstract  

 

It  has  become  increasingly  apparent  that  epigenePc  mechanisms  are  at  play  in  the  mechanisms  of  carcinogenesis.  MicroRNAs  (miRNAs)  have  been  idenPfied  as  a  new  layer  of  gene  regulatory  mechanisms  (Lujambio  and  Lowe,  2012).  The  importance  of  miRNAs  in  cancer  is  highlighted  by  the  observaPon  that  half  of  the  known  aberrant  expressions  of  miRNAs  are  located  in  cancer  associated  genomic  regions  (Wiklund  et  al.,  2010).  On  the  relaPonship  between  miRNAs  and  hepatocellular  carcinoma  (HCC)  in  humans,  several  studies  have  detected  the  aberrant  expression  of  specific  miRNAs  in  malignant  HCC,  compared  to  normal  hepatocyte  (Masaki,  2009).    There  is  widespread  and  unregulated  use  of  GBE  as  a  dietary  supplement  

by  the  American  public,  and  thus  is  a  significant  public  health  concern.  NTP’s  Ginkgo  biloba  leaf  extract  (GBE)  bioassay  has  indicated  that  chronic  GBE  exposure  to  B6C3F1  mouse  resulted  in  a  dose  dependent  increase  in  hepatocarcinogenicity.  Recent  transcriptomic  studies  on  GBE-­‐induced  HCC  indicated  dysregulated  cancer  gene  expression.  In  AddiPon,  increased  Ctnnb1  mutaPons  and  alteraPons  in  Wnt/Ctnnb1  signaling  were  demonstrated  in  GBE-­‐induced  HCC  compared  to  spontaneous  HCC  (Hoenerhoff  et  al.,  2013).  Determining  the  mechanisms  of  GBE-­‐induced  hepatocarcinogenicity  in  rodents  may  aid  in  assessing  the  health  risks  of  human  exposure.  We  hypothesize  that  genePc  and  epigenePc  pathways  dysregulated  in  GBE-­‐induced  mouse  HCC  may  reflect  key  pathways  altered  in  human  HCC.  The  objecPve  of  this  study  is  to  characterize  the  pamern  of  dysregulated  miRNAs  occurring  in  spontaneous  and  GBE-­‐induced  HCC  and  compare  it  to  the  corresponding  mRNA  alteraPons  in  HCC.

 

In  the  NTP  2-­‐year  mouse  GBE  bioassay,  there  was  a  dose  dependent  increase  in  HCC  (NTP  TR  578,  Table  1).  Using  the  Affymetrix  GeneChip®  miRNA  3.0  Array  plaoorm,  when  compared  to  normal  livers,  there  were  3  and  16  unique  differenPally  expressed  mouse  miRNAs  in  spontaneous  HCC  and  GBE-­‐induced  HCC,  respecPvely,  at  FDR  ≤  0.05  (Figure  1  and  2,  Table  2).  Analyzing  miRNA  and  the  corresponding  mRNA  array  data  in  IPA,  we  have  found  several  differenPally  altered  molecular  pathways  associated  with  HCC  development  in  both  GBE-­‐induced  HCCs  and  spontaneous  HCCs  (Tables  3,  4,  and  5).  Therefore,  these  data  show  that  GBE-­‐induced  HCCs  are  disPnguishable  from  spontaneous  HCC  in  terms  of  their  miRNA  expression  profile.   We  have  previously  reported  increased  Ctnnb1  mutaPons  and  alteraPons  in  

Wnt/Ctnnb1  signaling  in  GBE-­‐induced  HCC  compared  to  spontaneous  HCC  in  vehicle  controls.  In  addiPon,  in  GBE-­‐induced  HCC,  there  was  cytoplasmic  accumulaPon  of  CTNNB1  and  loss  of  normal  CDH1  membrane  immunoreacPvity,  with  accumulaPon  of  the  protein  in  the  cytoplasm  that  suggests  disrupPon  of  CTNNB1/CDH1  complexes  within  adherens  juncPons,  which  is  associated  with  a  more  malignant  phenotype  (Hoenerhoff  et  al.,  2013).  In  this  study,  we  found  4  miRNAs  that  were  uniquely  expressed  in  GBE-­‐induced  HCC  and  known  or  predicted  to  regulate  Wnt/Ctnnb1  signaling  (Table  5).  One  of  them,  miR-­‐31  was  strongly  downregulated  (83-­‐fold  by  QRT-­‐PCR)  in  GBE-­‐induced  HCC  with  no  change  in  spontaneous  HCC  compared  to  normal  livers  and  predicted  to  regulate  Cdk1,  which  was  upregurated  in  GBE  induced  HCC.  CDK1  plays  a  key  role  in  cell  cycle  regulaPon  and  increases  Src  kinase  acPvity  (Roskoski,  2005).  PhosphorylaPon  by  Src  kinase  disrupts  binding  of  CTNNB1/CDH1  and  results  in  loss  of  the  complexes  from  the  cell  surface  (Nelson  and  Nusse,  2004).  Therefore,  miR-­‐31  seems  to  indirectly  modulate  Wnt/Ctnnb1  signaling  in  GBE-­‐induced  HCC.  However,  further  studies  are  needed  to  evaluate  the  effect  of  miR-­‐31  on  Wnt/Ctnnb1  signaling.     In  order  to  determine  if  there  are  any  miRNAs  that  could  potenPally  serve  as  

a  biomarker  for  GBE  exposure  and/or  early  biomarkers  of  hepatocellular  carcinogenesis,  we  have  also  analyzed  the  miRNA  expression  in  livers  from  the  90-­‐day  GBE  mouse  study.  The  expression  of  miRs-­‐411,  300,  127  and  134  more  than  doubled  in  GBE-­‐treated  group  compared  to  vehicle  control  group  (Figure  3).  In  the  90-­‐day  GBE  study,  although  hepatocellular  hypertrophy  and  focal  necrosis  were  found  in  the  livers,  there  were  no  preneoplasPc  hepaPc  foci  (NTP  TR  578,  Table  1).  Since  these  miRNAs  were  uniquely  expressed  in  livers  from  90-­‐day  exposures  and  in  HCCs  from  GBE  exposure  or  arising  spontaneously,  they  could  serve  as  potenPal  biomarkers  for  GBE  exposure  or  hepatocellular  carcinogenesis.  These  results  suggest  that  these  miRNAs  might  be  useful  as  biomarkers  of  exposure  and  apical  endpoints.  However,  further  validaPons  in  prospecPve  studies  are  necessary  in  order  to  validate  these  findings.  In  addiPon,  although  this  QRT-­‐PCR  analysis  was  performed  using  miRNA  extracted  from  secPons  of  FFPE  livers,  all  the  miRNAs  analyzed  were  amplified  with  relaPve  ease,  indicaPng  that  archival  FFPE  Pssues  can  be  leveraged  for  miRNA-­‐based  biomarker  idenPficaPon.   

Introduc.on  

Materials  and  Methods  

Result  and  Discussion    Results  

MicroRNA  Profiling  of  Hepatocellular  Carcinomas  in  B6C3F1  Mice  Treated  with  Ginkgo  biloba  Extract  by  gavage      Yamashita  H1,2,  Pandiri  AR1,3,  Bhusari  S1,  Shockley  KR4,  Peddada  SD4,  Gerrish  KE5,  Rider  CV1,  Hoenerhoff  MJ1,  Sills  RC1.    

1Cellular  &  Molecular  Pathology  Branch,  NaPonal  Toxicology  Program,  NaPonal  InsPtute  of  Environmental  Health  Sciences  (NIEHS),  Research  Triangle  Park,  NC,  United  States,  2Taisho  PharmaceuPcal  Co.  Ltd.,  Saitama,  Japan,  3Experimental  Pathology  Laboratories,  Research  Triangle  Park,  NC,  United  States,  4BiostaPsPcs  Branch,  NIEHS,  Research  Triangle  Park,  NC,  United  States,  5Molecular  Genomics  Core  Laboratory,  NIEHS,  Research  Triangle  Park,  NC,  United  States.    

Table  1.  Incidences  of  select  hepaPc  lesions  in  B6C3F1  mice  treated  with  Ginkgo  biloba  leaf  extract  (GBE)  by  gavage  in  subchronic  (90-­‐day)  and  chronic  (2-­‐year)  NaPonal  Toxicology  Program  studies  (NTP  TR  578).

Figure  1.  (A)  Principal  component  analysis  (PCA)  of  global  miRNA  expression  profiles  demonstrated  nearly  disPnct  clustering  of  normal  liver  (blue),  spontaneous  HCC  (green)  and  GBE-­‐induced  HCC  (red)  samples.  (B)  Using  a  false  discovery  rate  threshold  of  5%,  3  and  16  unique  mouse  miRNAs  were  differenPally  expressed  in  spontaneous  HCC  and  GBE-­‐induced  HCC,  respecPvely.  The  number  in  the  parenthesis  indicates  the  number  of  differenPally  expressed  miRNAs  from  other  species  besides  mice.    

 

We  would  like  to  thank  DNTP  and  DIR,  NIEHS  for  funding  this  project.  We  would  also  like  to  thank  the  NIEHS  Microarray  core  and  the  Histology  core  Laboratory  in  the  Cellular  and  Molecular  Pathology  Branch  for  their  technical  assistance  on  this  project.    

Acknowledgements  

Table  2    

Table  2.  DifferenPally  expressed  miRNAs  and  their  target  genes  in  spontaneous  and  GBE-­‐induced  HCC  compared  to  age-­‐matched  normal  livers.    

Table  3  

Table  3.  RepresentaPve  altered  miRNA-­‐mRNA  interacPons  and  molecular  pathways.  Ingenuity  Pathway  Analysis  of  target  mRNAs  of  differenPally  altered  miRNAs  in  spontaneous  and  GBE-­‐induced  HCC  demonstrated  dysregulated  molecular  pathways  associated  with  hepatocarcinogenesis,  cell  cycle  progression,  cell  migraPon  and  cell  proliferaPon.    

Table  4.  DifferenPally  altered  miRNAs  from  other  species  that  are  staPsPcally  significant  (but  not  in  mice)  and  that  play  a  role  in  human  hepatocellular  carcinogenesis.  These  miRNA  sequences  are  typically  conserved  across  species  and  are  likely  to  be  relevant  even  in  mouse  hepatocellular  carcinogenesis.    

Table  5  

Table  5.  miRs-­‐329,  31,  145  and  433-­‐3p,  which  were  uniquely  expressed  in  GBE-­‐induced  HCC,  are  known  or  predicted  to  regulate  Wnt/Ctnnb1  signaling.    

Figure  2.  QuanPtaPve  RT-­‐PCR  validaPon  of  miRNA  array  expression  changes  observed  in  spontaneous  HCC  and  GBE-­‐induced  HCC  normalized  to  normal  livers.    

Figure  3.  QuanPtaPve  RT-­‐PCR  of  miRNAs  in  livers  from  B6C3F1  mice  treated  with  2000  mg/kg  GBE  for  90  days.  The  miRNA  expression  in  GBE  livers  was  normalized  to  normal  livers.    

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References  

•  GBE-­‐induced  mouse  HCCs  are  markedly  different  from  spontaneous  HCCs  in  terms  of  their  global  miRNA  expression  profile.

•  The  miRNA  and  mRNA  array  data  from  these  tumors  demonstrated  altered  molecular  pathways  associated  with  hepatocellular  carcinogenesis.

•  miRs-­‐31,  145,  329  and  433  that  were  uniquely  expressed  in  GBE-­‐induced  HCC  are  known  or  predicted  to  regulate  Wnt/Ctnnb1  signaling.    

•  miRs-­‐411,  300,  127  and  134  were  upregulated  in  the  livers  from  GBE-­‐treated  group  compared  to  vehicle  control  group  from  90-­‐day  GBE  mouse  study  and  these  miRNAs  could  serve  as  potenPal  biomarkers  for  GBE  exposure  or  hepatocellular  carcinogenesis.

Conclusions  

(B)  

a  10  male  and  female  B6C3F1  mice  were  exposed  to  0,  125,  250,  500,  1,000,  and  2,000  mg/kg  GBE  by  gavage,  once  daily,  5  days  per  week  for  90  days.  b  Severity  grade  based  on  0–4  grading  scale  (0  =  no  significant  lesion,  1  =  minimal,  2  =  mild,  3  =  moderate,  4  =  severe).  c  50  male  and  female  B6C3F1  mice  were  exposed  to  0,  200,  600,  and  2,000mg/kg  GBE  by  gavage,  once  daily,  5  days  per  week  for  two  years.  d  StaPsPcal  analysis  not  available  for  metastaPc  lesions.  Significantly  different  from  controls  *p  <  .05,  **p  <  .01  by  the  poly-­‐3  test.  

#1  Target  genes  that  showed  relaPonship  with  the  respecPve  miRNA  in  IPA  analysis  (experimentally  observed  or  predicted)  and  down-­‐  or  up-­‐regulated  in  GBE-­‐induced  HCC  microarray  analysis.

#2  No  informaPon  on  the  target  genes  was  found  in  IPA  knowledge  base  on  these  miRNAs.

Figure  3  

Figure  1  

Figure  2  

#1  Target  genes  that  showed  relaPonship  with  the  respecPve  miRNA  in  IPA  analysis  (experimentally  observed  or  predicted)  and  down-­‐  or  up-­‐regulated  in  GBE-­‐induced  HCC  microarray  analysis.

ê:  Known  to  decrease  the  diseases  or  funcPon  and  is  down-­‐regulated  in  the  dataset.  é:  Known  to  increase  the  diseases  or  funcPon  and  is  up-­‐regulated  in  the  dataset.  êé:  Literature  indicates  this  gene  is  involved  in  the  diseases  or  funcPon  but  does  not  indicate  whether  it  

increases  or  decreases  it.  And  the  gene  is  down-­‐  or  up-­‐regulated  in  the  dataset.  

Table  4  

Table  1  (A)  

GBE-­‐induced  HCC

Spontaneous  HCC

Normal  liver