JP2014525269A - 卵巣新生物に対する易罹患性及び/又は卵巣がんの予後若しくは悪性度を予測する方法 - Google Patents
卵巣新生物に対する易罹患性及び/又は卵巣がんの予後若しくは悪性度を予測する方法 Download PDFInfo
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Abstract
【選択図】なし
Description
本実施例は、卵巣がんの予後予測及びスクリーニングのための新規なDNAメチル化バイオマーカーを発見するものである。台湾の台北にあるTri-Service General Hospitalの国防医学院(National Defense Medical Center)において、患者とのインフォームドコンセントのもと組織試料を採取した。この研究は、治験審査委員会によって承認された。49の悪性組織及び12の良性組織を含む61名の独立した患者の卵巣試料を使用した。これらの試料を手術中に取得し、液体窒素中で急速凍結して分析まで−80℃で保存した。悪性細胞の存在を組織学的検査によって確認した。組織構造を評価するため、婦人科病理学者によって全ての標本を再調査した。最初の手術から進行性疾患までの時間として無増悪生存(PFS)を規定した。第1選択の標準的治療後に持続性疾患を呈する患者をPFS分析から除外した。全生存(OS)を最初の手術からEOCによる死亡までの時間として規定した。
台湾の台北にあるTri-Service General Hospitalの国防医学院において、患者とのインフォームドコンセントのもと組織試料を採取した。この研究は治験審査委員会によって承認された。患者には、卵巣上皮癌(EOC)を有する110名、良性卵巣腫瘍を有する60名、診断が組織学的サブタイプ及び組織学的グレードを含むものであった正常卵巣組織を有する28名が含まれる。手術中にこれらの試料を取得し、液体窒素中で急速凍結し、分析まで−80℃で保存した。組織学的検査によって悪性細胞の存在を確認した。組織構造を評価するため、婦人科病理医によって全ての標本を再調査した。無増悪生存(PFS)を最初の手術から進行性疾患までの時間として規定した。第1選択の標準的な治療後に持続的な疾患を呈する患者を、PFS分析から除外した。全生存(OS)を最初の手術からEOCによる死亡までの時間として規定した。
Claims (28)
- 被検体における卵巣新生物のリスク又は易罹患性を予測する方法であって、前記被検体より得られた卵巣新生物試料中の以下の1又は複数の遺伝子:NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、CACYBP、HIST1H2AJ、C1orf158、A4GALT、MLN、HIST1H3C、STC2、ATG4A、ENG、HIST1H2BN、MGST2及びTHRB、又はそれらと少なくとも80%の類似性を有するポリヌクレオチド配列のDNAメチル化を評価することを含み、DNAメチル化の変化が、前記被検体が卵巣新生物に易罹患性であることを示す、方法。
- 卵巣新生物と診断された被検体における予後又は悪性度を予測する方法であって、前記被検体から得られた卵巣がん試料中の以下の1又は複数の遺伝子:NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、CACYBP、HIST1H2AJ、C1orf158、A4GALT、MLN、HIST1H3C、STC2、ATG4A、ENG、HIST1H2BN、MGST2及びTHRB、又はそれらと少なくとも80%の類似性を有するポリヌクレオチド配列のDNAメチル化を評価することを含み、DNAメチル化の変化が、予後不良又は悪性卵巣がんを示す、方法。
- 非がん細胞において観察されるDNAメチル化と比較した場合に、NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、ATG4A、HIDT1H2BN、THRB及びMGST2の1又は複数のDNAの高メチル化、及び/又は非がん細胞において観察されるDNAメチル化と比較した場合に、CACYBP、HIST1H2AJ、C1orf158、A4GALT、MLN、HIST1H3C、STC2及びENGの1又は複数のDNA低メチル化が予後不良を示す、請求項1又は2に記載の方法。
- DNA高メチル化を伴う遺伝子がATG4A、HIST1H2BN、ADRA1A、CACNB2、GATA4、KCNA6、POU4F2、HS3ST2若しくはNEFH、又はそれらの任意の組合せである、請求項3に記載の方法。
- DNA高メチル化を伴う遺伝子がATG4A、HIST1H2BN、CEACAM4、GATA4若しくはIGSF21、又はそれらの任意の組合せである、請求項3に記載の方法。
- DNA高メチル化を伴う遺伝子がCEACAM4、GATA4若しくはIGSF21、又はそれらの任意の組合せである、請求項3に記載の方法。
- DNA高メチル化を伴う遺伝子がPOU4F2、NEFH、HS3ST2、又はそれらの任意の組合せである、請求項3に記載の方法。
- DNA低メチル化を伴う遺伝子がCACYBP若しくはC1orf158、又はそれらの組合せである、請求項3に記載の方法。
- DNA低メチル化を伴う遺伝子がCACYBP若しくはMLN、又はそれらの組合せである、請求項3に記載の方法。
- 卵巣がんを有する被検体に対する処置決定を行う方法であって、前記被検体に有効量の脱メチル化剤を投与することを含み、前記被検体が、非がん細胞において観察されるDNAメチル化と比較した場合に、NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、ATG4A、HIDT1H2BN、THRB及びMGST2の1若しくは複数、又はそれらと少なくとも80%の類似性を有するポリヌクレオチド配列のDNA高メチル化を呈する、方法。
- 前記脱メチル化剤が、5−アザ−2’−デオキシシチジン、5−アザ−シチジン、ゼブラリン、プロカイン、又はL−エチオニンである、請求項10に記載の方法。
- DNA高メチル化を伴う遺伝子がATG4A、HIST1H2BN、CEACAM4、GATA4、NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3若しくはKCNA6、又はそれらの任意の組合せである、請求項10に記載の方法。
- DNA高メチル化を伴う遺伝子がATG4A、HIST1H2BN、ADRA1A、CACNB2、GATA4、KCNA6、POU4F2、HS3ST2若しくはNEFH、又はそれらの任意の組合せである、請求項10に記載の方法。
- DNA高メチル化を伴う遺伝子がATG4A、HIST1H2BN、CEACAM4、GATA4若しくはIGSF21、又はそれらの任意の組合せである、請求項10に記載の方法。
- DNA高メチル化を伴う遺伝子がCEACAM4、GATA4若しくはIGSF21、又はそれらの任意の組合せである、請求項10に記載の方法。
- DNA高メチル化を伴う遺伝子がPOU4F2、NEFH若しくはHS3ST2、又はそれらの任意の組合せである、請求項10に記載の方法。
- 卵巣がんにおける予後不良又は悪性腫瘍を有する被検体に対する治療計画を決定する方法であって、前記被検体に化学療法を提供することを含み、前記被検体が、非がん細胞において観察されるDNAメチル化と比較した場合に、NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、ATG4A、HIDT1H2BN、THRB及びMGST2の1若しくは複数、又はそれらと少なくとも80%の類似性を有するポリヌクレオチド配列のDNA高メチル化、及び/又は非がん細胞において観察されるDNAメチル化と比較した場合に、CACYBP、HIST1H2AJ、C1orf158、A4GALT、MLN、HIST1H3C、STC2及びENGの1又は複数のDNA低メチル化を有する、方法。
- DNA高メチル化を伴う遺伝子がCEACAM4、GATA4、NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3若しくはKCNA6、又はそれらの任意の組合せである、請求項17に記載の方法。
- DNA高メチル化を伴う遺伝子がATG4A、HIST1H2BN、ADRA1A、CACNB2、GATA4、KCNA6、POU4F2、HS3ST2若しくはNEFH、又はそれらの任意の組合せである、請求項17に記載の方法。
- DNA高メチル化を伴う遺伝子がCEACAM4、GATA4若しくはIGSF21、又はそれらの任意の組合せである、請求項17に記載の方法。
- DNA高メチル化を伴う遺伝子がPOU4F2、NEFH若しくはHS3ST2、又はそれらの任意の組合せである、請求項17に記載の方法。
- DNA低メチル化を伴う遺伝子がCACYBP、HIST1H2AJ若しくはC1orf158、又はそれらの任意の組合せである、請求項17に記載の方法。
- DNA低メチル化を伴う遺伝子がCACYBP若しくはC1orf158、又はそれらの組合せである、請求項17に記載の方法。
- DNA低メチル化を伴う遺伝子がCACYBP若しくはMLN、又はそれらの組合せである、請求項17に記載の方法。
- 前記化学療法がアジュバント化学療法である、請求項17に記載の方法。
- 卵巣新生物のリスク若しくは易罹患性若しくは予後を予測する、悪性度を検出する及び/又は卵巣がんを有する被検体に対する処置決定を行うキットであって、該キットはNPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、CACYBP、HIST1H2AJ、C1orf158、A4GALT、MLN、HIST1H3C、STC2、ATG4A、ENG、HIST1H2BN、MGST2及びTHRBの1又は複数の遺伝子、又はそれらと少なくとも80%の類似性を有するポリヌクレオチド配列のメチル化シトシン残基と非メチル化シトシン残基とを区別する試薬を含み、非がん細胞において観察されるDNAメチル化と比較した場合に、NPTX2、TNNI1、POU4F2、HS3ST2、CACNB2、TBX20、OR2L13、IGSF21、CD248、ADRA1A、NEFH、BNIP3、C1QTNF3、KCNA6、CEACAM4、CRNN、HFE2、TWIST1、GATA4、ATG4A、HIDT1H2BN、THRB及びMGST2の1若しくは複数のDNA高メチル化、及び/又は非がん細胞において観察されるDNAメチル化と比較した場合に、CACYBP、HIST1H2AJ、C1orf158、A4GALT、MLN、HIST1H3C、STC2及びENGの1若しくは複数のDNA低メチル化が卵巣がんにおける予後不良又は悪性腫瘍を示す、キット。
- 前記新生物の試料が、被検体から得られるか、又は被検体内に存在する試料である、請求項1、2、8、13及び19のいずれか1項に記載の方法。
- 前記新生物の試料が、組織、組織試料、若しくは細胞試料、腫瘍、腫瘍試料、生体液、腹腔液、血液、血清、リンパ、又は髄液から得られる、請求項1、2、8、13及び19のいずれか1項に記載の方法。
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WO2019108906A1 (en) * | 2017-11-30 | 2019-06-06 | Baylor College Of Medicine | Genomic dna methylation associated with disease prediction |
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US7507536B2 (en) * | 2005-10-07 | 2009-03-24 | The Johns Hopkins University | Methylation markers for diagnosis and treatment of ovarian cancer |
JP2010538637A (ja) * | 2007-09-17 | 2010-12-16 | コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ | 卵巣癌疾患の解析方法 |
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WO2017221927A1 (ja) | 2016-06-20 | 2017-12-28 | 国立研究開発法人国立がん研究センター | 卵巣がんの予後診断マーカーとしてのmmp1遺伝子転写産物と検査法 |
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WO2013033333A1 (en) | 2013-03-07 |
CN104204222A (zh) | 2014-12-10 |
NZ622148A (en) | 2016-06-24 |
EP2751288A4 (en) | 2015-09-30 |
IL231206A0 (en) | 2014-04-30 |
AU2012301937A1 (en) | 2014-03-27 |
US20150072947A1 (en) | 2015-03-12 |
EP2751288A1 (en) | 2014-07-09 |
CA2847290A1 (en) | 2013-03-07 |
SG11201400269YA (en) | 2014-09-26 |
HK1204482A1 (en) | 2015-11-20 |
TW201326481A (zh) | 2013-07-01 |
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