WO2022191566A1 - 췌장암의 진단용 조성물 - Google Patents
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
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Abstract
Description
유전자_ID | 전사체_ID | 명칭 | 배수 | |
122618 | NM_001308174,NM_138790 | PLD4 | phospholipase D family member 4 | -2.007829 |
3164 | NM_001202233,NM_001202234,NM_002135,NM_173157 | NR4A1 | nuclear receptor subfamily 4 group A member 1 | -2.859995 |
51348 | NM_001291822,NM_001291823,NM_001366534,NM_016523 | KLRF1 | killer cell lectin like receptor F1 | -2.460315 |
3399 | NM_002167 | ID3 | inhibitor of DNA binding 3, HLH protein | 2.522447 |
유전자 | 형태 | 서열 (5' -> 3') |
PLD4 (Ref. NM_138790) | 정방향 프라이머 | CAA ATT CTG GGT TGT GGA TGG |
역방향 프라이머 | AGG TGG CTG CAG TTA TAG ATG | |
NR4A1 (Ref. NM_002135.5) | 정방향 프라이머 | GACAACGCTTCATGCCAG |
역방향 프라이머 | TTGTTAGCCAGGCAGATGTAC | |
KLRF1 (Ref. NM_016523) | 정방향 프라이머 | GAA AAG GAG TTC TGC CCA AAC |
역방향 프라이머 | AGA AAC CAA CAG GAT CAA GGA G | |
IL7R (Ref. NM_002185.5) | 정방향 프라이머 | GTA GTC ATC ACT CCA GAA AGC |
역방향 프라이머 | ACC TGG AAG AGG AGA GAA TAG |
유전자 | 형태 | 서열 (5' -> 3') |
ID3 (Ref. NM_002167) | 정방향 프라이머 | GAC TAC ATT CTC GAC CTG CAG |
역방향 프라이머 | TCG TTG GAG ATG ACA AGT TCC |
환자군 | |
췌장암 환자군 (n=50) | 비췌장암 환자군 (n=222) - 정상인 (n=61) - 고위험군(만성췌장염, 췌장물혹, 췌관 확장 등) (n=56) - 양성 췌장 질환군 (n=48) - 기타 소화기계 암종군(담도암, 위암, 대장암, 간암 등) (n=54) - 기타 (n=3) |
Name | Sequence (5'-3') | Reporter 5' | Quencher 3' | |
1 | PLD4-FAM | TCT GAC GCA GGT GAA GGA GCT TG | FAM | ZEN/IBFQ |
2 | IL7R-FAM | CAG TTG GAA GTG AAT GGA TCG CAG C | FAM | ZEN/IBFQ |
3 | ID3-FAM | CTC GGC TGT CTG GAT GGG AAG G | FAM | ZEN/IBFQ |
변수 | 단일 마커 모형 | PLD4+ID3+IL7R 조합 마커 모형 | |||||||
Intercept | p-value | Beta(SE) | OR(95% CI) | p-value | Beta(SE) | OR(95% CI) | p-value | VIF | |
Intercept | -0.034331(0.3140) | 0.9129 | -0.096451(0.0208) | 0.908(0.872-0.946) | <.0001 | -0.229438(0.0395) | 0.795(0.736-0.859) | <.0001 | 1.1554 |
PLD4 | -2.165325(0.3397) | <.0001 | 0.000603(0.0003) | 1.001(1.000-1.001) | 0.0179 | 0.001251(0.0004) | 1.001(1.000-1.002) | 0.0025 | 1.6804 |
IL7R | -2.116365(0.2716) | <.0001 | 0.072584(0.0237) | 1.075(1.026-1.126) | 0.0022 | 0.134571(0.0392) | 1.144(1.059-1.235) | 0.0006 | 1.6835 |
ID3 | -0.034331(0.3140) | 0.9129 | -0.096451(0.0208) | 0.908(0.872-0.946) | <.0001 | -0.229438(0.0395) | 0.795(0.736-0.859) | <.0001 | 1.1554 |
모델 | Optimal cut-off point | AUC (95% CI) | Sensitivity(95% CI) | Specificity(95% CI) | Accuracy (95% CI) | PPV (95% CI) | NPV (95% CI) |
PLD4 | <18.8693 | 0.727(0.662-0.793) | 0.900(0.817-0.983) | 0.523(0.457-0.588) | 0.592(0.534-0.650) | 0.298(0.225-0.371) | 0.959(0.923-0.994) |
IL7R | >1025.40733 | 0.621(0.533-0.709) | 0.660(0.529-0.791) | 0.568(0.502-0.633) | 0.585(0.526-0.643) | 0.256(0.181-0.331) | 0.881(0.828-0.934) |
ID3 | >8.7021 | 0.640(0.543-0.737) | 0.620(0.485-0.755) | 0.716(0.657-0.776) | 0.699(0.644-0.753) | 0.330(0.235-0.425) | 0.893(0.848-0.939) |
PLD4+ID3+IL7R | >0.22016 | 0.860(0.814-0.907) | 0.840(0.738-0.942) | 0.788(0.735-0.842) | 0.798(0.750-0.846) | 0.472(0.368-0.576) | 0.956(0.927-0.986) |
Claims (21)
- PLD4(Phospholipase D Family Member 4), NR4A1(nuclear receptor subfamily 4 group A member 1), KLRF1(Killer Cell Lectin Like Receptor F1) 및 ID3(Inhibitor of DNA binding 3, HLH protein)로 이루어진 군에서 선택된 1종 이상의 단백질 또는 이를 암호화하는 유전자의 발현 수준을 측정하는 제제를 유효 성분으로 포함하는 췌장암의 진단용 조성물.
- 제1항에 있어서,상기 진단용 조성물은 IL7R(Interleukin 7 receptor) 단백질 또는 이를 암호화하는 유전자의 발현 수준을 측정하는 제제를 추가로 더 포함하는, 진단용 조성물.
- 제1항에 있어서,상기 단백질의 발현 수준을 측정하는 제제는 상기 단백질에 특이적으로 결합하는 항체, 올리고펩타이드, 리간드, PNA(peptide nucleic acid) 및 앱타머(aptamer)로 이루어진 군에서 선택된 1종 이상을 포함하는, 진단용 조성물.
- 제1항에 있어서,상기 유전자의 발현 수준을 측정하는 제제는 상기 유전자에 특이적으로 결합하는 프라이머, 프로브 및 안티센스 뉴클레오티드로 이루어진 군에서 선택된 1종 이상을 포함하는, 진단용 조성물.
- 제1항에 있어서,상기 진단용 조성물은 목적하는 개체에서 분리된 액체 생검(liquid biopsy)에 대한 것인, 진단용 조성물.
- 제1항에 있어서,상기 진단용 조성물은 암의 발병, 성장, 진행 또는 전이 가능성을 예측; 암과 췌장 질환을 구별; 또는 암종을 구별;하기 위한 것인, 진단용 조성물.
- 제1항 내지 제6항 중 어느 한 항의 진단용 조성물을 포함하는 췌장암의 진단용 키트.
- 제7항에 있어서,상기 키트는 RT-PCR 키트, DNA 칩 키트, ELISA 키트, 단백질 칩 키트, 래피드(rapid) 키트 또는 MRM(Multiple reaction monitoring) 키트인, 진단용 키트.
- 목적하는 개체로부터 분리된 생물학적 시료에서 PLD4(Phospholipase D Family Member 4), NR4A1(nuclear receptor subfamily 4 group A member 1), KLRF1(Killer Cell Lectin Like Receptor F1) 및 ID3(Inhibitor of DNA binding 3, HLH protein)로 이루어진 군에서 선택된 1종 이상의 단백질 또는 상기 단백질을 암호화하는 유전자의 발현 수준을 측정하는 단계를 포함하는, 췌장암의 진단을 위한 정보 제공 방법.
- 제9항에 있어서,상기 생물학적 시료는 전혈(whole blood), 백혈구(leukocytes), 말초혈액 단핵 세포(peripheral blood mononuclear cells), 백혈구 연층(buffy coat), 혈장(plasma), 혈청(serum), 객담(sputum), 눈물(tears), 점액(mucus), 세비액(nasal washes), 비강 흡인물(nasal aspirate), 호흡(breath), 소변(urine), 정액(semen), 침(saliva), 복강 세척액(peritoneal washings), 복수(ascites), 낭종액(cystic fluid), 뇌척수막 액(meningeal fluid), 양수(amniotic fluid), 선액(glandular fluid), 췌장액(pancreatic fluid), 림프액(lymph fluid), 흉수(pleural fluid), 유두 흡인물(nipple aspirate), 기관지 흡인물(bronchial aspirate), 활액(synovial fluid), 관절 흡인물(joint aspirate), 기관 분비물(organ secretions), 세포(cell), 세포 추출물(cell extract) 및 뇌척수액(cerebrospinal fluid) 등으로 이루어진 군에서 선택된 1종 이상인, 정보 제공 방법.
- 제9항에 있어서,상기 생물학적 시료는 액체 생검(liquid biopsy)인, 정보 제공 방법.
- 제9항에 있어서,상기 정보 제공 방법은 상기 목적하는 개체로부터 분리된 생물학적 시료에서 IL7R(Interleukin 7 receptor) 단백질 또는 이를 암호화하는 유전자의 발현 수준을 측정하는 단계를 추가로 더 포함하는, 정보 제공 방법.
- 제9항에 있어서,상기 단백질의 발현 수준을 측정하는 제제는 상기 단백질에 특이적으로 결합하는 항체, 올리고펩타이드, 리간드, PNA(peptide nucleic acid) 및 앱타머(aptamer)로 이루어진 군에서 선택된 1종 이상을 포함하는, 정보 제공 방법.
- 제9항에 있어서,상기 단백질의 발현 수준의 측정은 단백질 칩 분석, 면역 측정법, 리간드 바인딩 어세이, MALDI-TOF(Matrix Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry) 분석, SELDI-TOF(Sulface Enhanced Laser Desorption/Ionization Time of Flight Mass Spectrometry) 분석, 방사선 면역 분석, 방사 면역 확산법, 오우크테로니 면역 확산법, 로케트 면역전기영동, 조직면역 염색, 보체 고정 분석법, 2차원 전기영동 분석, 액상 크로마토그래피-질량분석(liquid chromatography-Mass Spectrometry, LC-MS), LC-MS/MS(liquid chromatography-Mass Spectrometry/ Mass Spectrometry), 웨스턴 블랏팅, ELISA(enzyme linked immunosorbentassay) 또는 다중 반응 모니터링 (multiple reaction monitoring; MRM) 방법에 의하는, 정보 제공 방법.
- 제9항에 있어서,상기 유전자의 발현 수준을 측정하는 제제는 상기 유전자에 특이적으로 결합하는 프라이머, 프로브 및 안티센스 뉴클레오티드로 이루어진 군에서 선택된 1종 이상을 포함하는, 정보 제공 방법.
- 제9항에 있어서,상기 유전자의 발현 수준의 측정은 역전사 중합효소반응(RT-PCR), 경쟁적 역전사 중합효소반응(Competitive RT-PCR), 실시간 역전사 중합효소반응(Real-time RT-PCR), RNase 보호 분석법(RPA; RNase protection assay), 노던 블랏팅(Northern blotting) 또는 DNA 칩에 의하는, 정보 제공 방법.
- 제9항에 있어서,상기 목적하는 개체의 생물학적 시료에 대하여 측정된 PLD4, NR4A1 및 KLRF1으로 이루어진 군에서 선택된 1종 이상의 단백질 또는 상기 단백질을 암호화하는 유전자의 발현 수준이 대조군에 비하여 낮은 경우, 상기 목적하는 개체에 췌장암이 발병하였거나 발병할 가능성이 높은 것으로 예측하는, 정보 제공 방법.
- 제12항에 있어서,상기 목적하는 개체의 생물학적 시료에 대하여 측정된 ID3 및 IL7R 중 적어도 하나의 단백질 또는 상기 단백질을 암호화하는 유전자의 발현 수준이 대조군에 비하여 높은 경우, 상기 목적하는 개체에 췌장암이 발병하였거나 발병할 가능성이 높은 것으로 예측하는, 정보 제공 방법.
- 제17항 또는 제18항에 있어서,상기 췌장암이 발병하였거나 발병 가능성이 높은 것으로 예측하는 것은 췌장암의 발병, 성장, 진행 또는 전이 가능성을 예측; 췌장암을 췌장 질환과 구별; 또는 다른 암종과 구별;하는 것을 포함하는, 정보 제공 방법.
- PLD4(Phospholipase D Family Member 4), NR4A1(nuclear receptor subfamily 4 group A member 1), KLRF1(Killer Cell Lectin Like Receptor F1) 및 ID3(Inhibitor of DNA binding 3, HLH protein)로 이루어진 군에서 선택된 1종 이상의 단백질 또는 이를 암호화하는 유전자를 포함하는 췌장암의 진단용 바이오마커.
- 제20항에 있어서,상기 바이오마커는 IL7R(Interleukin 7 receptor) 단백질 또는 이를 암호화하는 유전자를 더 포함하는, 바이오마커.
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CN117187385B (zh) * | 2023-08-18 | 2024-05-14 | 上海爱谱蒂康生物科技有限公司 | 生物标志物在制备预测和/或诊断utuc的试剂盒中的应用 |
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