JP5164855B2 - 子宮内膜または子宮癌を評価するためのhe4及びそのほかの生化学的マーカーの使用 - Google Patents
子宮内膜または子宮癌を評価するためのhe4及びそのほかの生化学的マーカーの使用 Download PDFInfo
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- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
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- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
- G01N33/57449—Specifically defined cancers of ovaries
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
Description
この出願の発明に関連する先行技術文献情報としては、以下のものがある(国際出願日以降国際段階で引用された文献及び他国に国内移行した際に引用された文献を含む)。
本願明細書に使用される「検体」の用語は、具体的に患者と関連があり、その患者に関する特定の情報を定め、計算し、または、推論できる物質を意味する。検体は全体的または部分的に、患者由来の生体物質から構成し得る。検体は、また、前記患者に関する情報を提供する検体で検査が行なえるように患者に接触させた物質であってもよい。検体は、さらに患者のものではないが、後に、第1の物質で患者に関する情報を定めるのに検査が出来る、他の物質に接触した物質でもよく、例えばプローブまたはメスの洗浄液でよい。検体は、当業者がいずれにしてもその検体から患者に関する情報を定めることが出来る限り、患者以外の生体物質源に接触していてもよい。検体ではない、外来の物質または情報を利用することで決定的に患者を当該検体に関連付け得ることも判っている。非限定的なの例によると、二重盲検法は検体と患者とを一致させるために図表かデータベースが必要である。
1EVEKTACPSGKKAREIDES 配列ID番号:14
さらに、MAb K−1(Chang et al.,1996 Proc.Nat.Acad.Sci.USA 93:136;MAb K−1は、例えばSignet Laboratories,Inc.,マサチュセツ州Dedhamから取得できる)。またはモノクローナル抗体OV569、4H3、3G3、または米国特許番号6,770,445明細書に記載のような1A6の免疫特異性結合を競合的に抑制する抗原結合部位を有する、少なくとも一種の抗体と反応性のある、少なくとも一個の抗原決定基を有する。
一般法
本実施例で使用した基準組換えDNAおよび分子クローニング技術は、当該技術分野で公知であり、以下に記載されている。Sambrook,J.,Fritsch,E.F.and Maniatis,T.Molecular Cloning:A Laboratory Manual;Cold Spring Harbor Laboratory Press:Cold Spring Harbor,(1989)(Maniatis)およびT.J.Silhavy,M.L.Bennan,and L.W.Enquist,Experiments with Gene Fusions,Cold Spring Harbor Laboratory,ニューヨーク州 Cold Spring Harbor,N.Y.(1984)およびAusubel,F.M.et al.,Current Protocols in Molecular Biology,pub. by Greene Publishing Assoc.and Wiley−Interscience(1987)。
米国では、およそ40,880件の子宮癌が新規に診断され、7,310人が毎年死亡している。子宮癌は、外科的にステージされ、75%が疾病ステージ1を示す。CA125の血清レベルは、進行期疾病を示す患者の約75%で上昇しているが、初期疾病の患者の内僅か17%が上昇しているだけである。再発疾病の検知用にCA125を使用するのは、よくても限定されている。無症候性で再発する疾病に罹った患者の僅か25%でCA125が上昇するだけである。早期の再発疾病を示す、よりよいマーカーが必要である。この研究の目的は、新規な血清腫瘍マーカーHE4の価値を検討し、それを子宮内膜癌用マーカーとしてCA−125と比較することであった。
Claims (30)
- 患者が子宮内膜または子宮癌に罹患しているかどうかを判定するためのHE4の使用であって、前記判定は、前記患者から採取した検体中のHE4の発現を判定する工程を含み、HE4の高い発現は、前記患者が子宮内膜または子宮癌に罹患している指標である、前記HE4の使用。
- 請求項1記載のHE4の使用において、前記検体は、固体の組織検体である、使用。
- 請求項1記載のHE4の使用において、前記検体は、患者から採取した体液である、使用。
- 請求項3記載のHE4の使用において、前記体液は、血液、血清、腹水、および膣液から成る群から選択するものである、使用。
- 請求項1記載のHE4の使用において、前記検体は、前記患者に接触した液体である、使用。
- 請求項5記載のHE4の使用において、前記液体は、腹膜の洗浄液および膣洗液から成る群から選択されるものである、使用。
- 請求項1記載のHE4の使用において、前記検体中のHE4の発現は参照値と比較されるものである、使用。
- 請求項7記載のHE4の使用において、前記参照値は、子宮内膜または子宮癌に罹患していない患者のHE4の発現に対応するものである、使用。
- 請求項1記載のHE4の使用において、前記検体中のHE4の発現は、初期に前記患者から採取した初期の検体中のHE4の発現と比較されるものである、使用。
- 請求項1記載のHE4の使用において、前記判定は、さらに、
CA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択した第2マーカーの前記検体中の発現を判定する工程を含み、前記第2マーカーの高い発現は、前記患者が子宮内膜または子宮癌に罹患しているさらなる指標となるものである、使用。 - 請求項1記載のHE4の使用において、前記判定は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)両者の発現を判定する工程を含み、CA125およびSMRPのいずれかの高い発現は、患者が子宮内膜または子宮癌に罹患しているさらなる指標となるものである、使用。 - 子宮内膜または子宮癌罹患患者の治療に対する応答を判定するためのHE4の使用であって、治療期間中の異なる時期に前記患者から採取した検体中のHE4の発現を判定する工程を含み、後期における減少したHE4の発現は、患者が前記治療に応答していることを示すものである、前記HE4の使用。
- 請求項12記載のHE4の使用において、前記判定は、さらに、
CA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択される第2マーカーの前記検体中の発現を判定する工程を含み、前記第2マーカーの減少した発現は、前記患者が前記治療に応答しているさらなる指標となるものである、使用。 - 請求項12記載のHE4の使用において、前記判定は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)両者の発現を判定する工程を含み、CA125およびSMRPの何れかの減少した発現は、前記患者が前記治療に応答しているさらなる指標となるものである、使用。 - 子宮内膜または子宮癌の治療を受けたことのある患者の再発を判定するためのHE4の使用であって、前記判定は、治療後、前記患者から採取した検体中のHE4の発現を判定し、HE4の高い発現は、前記患者が子宮内膜または子宮癌が再発していることを示すものである、前記HE4の使用。
- 請求項15記載のHE4の使用において、前記判定は、さらに、
CA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択した第2マーカーの前記検体中の発現を判定する工程を含み、前記第2マーカーの高い発現は、前記患者に子宮内膜または子宮癌が再発しているさらなる指標となるものである、使用。 - 請求項15記載のHE4の使用において、前記判定は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)両者の発現を判定する工程を含み、CA125およびSMRPの何れかの高い発現は、前記患者が子宮内膜または子宮癌が再発しているさらなる指標となるものである、使用。 - 請求項15記載のHE4の使用において、前記治療後のHE4の発現は複数回判定されるものであり、HE4の発現の増大は、前記患者に子宮内膜または子宮癌が再発していることを示すものである、使用。
- 患者が子宮内膜または子宮癌を発症する可能性を判定するためのHE4の使用であって、前記判定は、前記患者から採取した検体中のHE4の発現を判定する工程を含み、HE4の高い発現は、前記患者が子宮内膜または子宮癌を発症する可能性の増大と相互に関連するものである、前記HE4の使用。
- 請求項19記載のHE4の使用において、前記判定は、さらに、前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択される第2マーカーの発現を判定する工程を含み、前記第2マーカーの高い発現は、前記患者が子宮内膜または子宮癌を発症するさらなる指標となるものである、使用。
- 請求項19記載のHE4の使用において、前記判定は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)両者の発現を判定する工程を含み、CA125およびSMRPの何れかの高い発現は、前記患者が子宮内膜または子宮癌を発症するさらなる指標となるものである、使用。 - 子宮内膜または子宮癌罹患患者の腫瘍の病期を分類するためのHE4の使用であって、前記分類は、前記患者から採取した検体のHE4の発現を判定する工程を含み、HE4の発現の増大は、前記癌の病期がより進行していることを示すものである、前記HE4の使用。
- 請求項22記載のHE4の使用において、前記分類は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択される第2マーカーの発現を判定する工程を含み、前記第2マーカーの高い発現は、前記癌の病期がより進行していることを示すものである、使用。 - 請求項22記載のHE4の使用において、前記分類は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)SMRP両者の発現を判定する工程を含み、CA125およびSMRPの何れかの高い発現は、前記癌の病期がより進行していることを示すものである、使用。 - 子宮内膜または子宮癌罹患患者の腫瘍の病期を分類するためのHE4の使用であって、前記分類は、前記患者から採取した検体のHE4の発現を判定する工程を含み、HE4の発現の増大は、前記癌の悪性度がより高いことを示すものである、前記HE4の使用。
- 請求項25記載のHE4の使用において、前記分類は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択される第2マーカーの発現を判定する工程を含み、前記第2マーカーの高い発現は、前記癌の悪性度が高いことをさらに示すものである、使用。 - 請求項25記載のHE4の使用において、前記分類は、さらに、
前記検体中のCA125および可溶性メソテリン関連ペプチド(SMRP)両者の発現を判定する工程を含み、CA125およびSMRPの何れかの高い発現は、前記癌の悪性度がより高いことをさらに示すものである、使用。 - 子宮内膜または子宮癌と診断された患者の治療的介在の必要性を判定するためのHE4の使用であって、前記判定は、前記患者から採取した検体のHE4の発現を判定する工程を含み、HE4の高い発現は、前記患者の治療的介在の必要性を示すものである、前記HE4の使用。
- 請求項28記載のHE4の使用において、前記判定は、さらに、
CA125および可溶性メソテリン関連ペプチド(SMRP)から成る群から選択される第2マーカーの前記検体中の発現を判定する工程を含み、前記第2マーカーの高い発現は、前記患者の治療的介在の必要性をさらに示すものである、使用。 - 請求項28記載のHE4の使用において、前記治療的介在は、化学療法である、使用。
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