ES2641093T3 - Método de detección del cáncer de cuello uterino inducido por el HPV - Google Patents
Método de detección del cáncer de cuello uterino inducido por el HPV Download PDFInfo
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- ES2641093T3 ES2641093T3 ES12783347.3T ES12783347T ES2641093T3 ES 2641093 T3 ES2641093 T3 ES 2641093T3 ES 12783347 T ES12783347 T ES 12783347T ES 2641093 T3 ES2641093 T3 ES 2641093T3
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- mir124
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- 206010008342 Cervix carcinoma Diseases 0.000 title abstract 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 title abstract 2
- 201000010881 cervical cancer Diseases 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 238000012216 screening Methods 0.000 title description 3
- 230000011987 methylation Effects 0.000 abstract description 13
- 238000007069 methylation reaction Methods 0.000 abstract description 13
- 230000003902 lesion Effects 0.000 abstract description 6
- 238000012360 testing method Methods 0.000 abstract description 4
- 206010028980 Neoplasm Diseases 0.000 abstract description 2
- 108090000623 proteins and genes Proteins 0.000 abstract description 2
- 230000004075 alteration Effects 0.000 abstract 2
- 210000001744 T-lymphocyte Anatomy 0.000 abstract 1
- 230000035800 maturation Effects 0.000 abstract 1
- 239000002243 precursor Substances 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108091007781 MIR124-1 Proteins 0.000 description 9
- 108091007778 MIR124-2 Proteins 0.000 description 9
- 108091069019 Homo sapiens miR-124-1 stem-loop Proteins 0.000 description 8
- 108091069008 Homo sapiens miR-124-2 stem-loop Proteins 0.000 description 8
- 101150070189 CIN3 gene Proteins 0.000 description 6
- 108091069007 Homo sapiens miR-124-3 stem-loop Proteins 0.000 description 5
- 102100038546 Fibronectin type III and SPRY domain-containing protein 1 Human genes 0.000 description 3
- 101001030521 Homo sapiens Fibronectin type III and SPRY domain-containing protein 1 Proteins 0.000 description 3
- 230000035945 sensitivity Effects 0.000 description 3
- 108091093088 Amplicon Proteins 0.000 description 2
- 238000010222 PCR analysis Methods 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 108091056924 miR-124 stem-loop Proteins 0.000 description 2
- 239000000523 sample Substances 0.000 description 2
- 101150061050 CIN1 gene Proteins 0.000 description 1
- 201000009030 Carcinoma Diseases 0.000 description 1
- 241001061257 Emmelichthyidae Species 0.000 description 1
- 102100021519 Hemoglobin subunit beta Human genes 0.000 description 1
- 108091005904 Hemoglobin subunit beta Proteins 0.000 description 1
- 101150005988 cin2 gene Proteins 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 108091048120 miR-124-3 stem-loop Proteins 0.000 description 1
- 238000009595 pap smear Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000007790 scraping Methods 0.000 description 1
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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
- C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/154—Methylation markers
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/178—Oligonucleotides characterized by their use miRNA, siRNA or ncRNA
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Analytical Chemistry (AREA)
- Zoology (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Physics & Mathematics (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Hospice & Palliative Care (AREA)
- Biophysics (AREA)
- Oncology (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
Un método de detección de la aparición de lesiones cervicales precancerosas de alto grado inducidas por HPV y/o cánceres de cuello uterino invasivos inducidos por HPV que comprende ensayar una muestra de lavado cervicovaginal para determinar la presencia de una alteración en la metilación de la proteína asociada a la maduración de linfocitos T (MAL) y hsa-miR124, en el que dicha alteración indica la presencia de lesiones precursoras inducidas por HPV con potencial invasivo y/o cánceres invasivos inducidos por HPV.
Description
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mientras que no fue detectada la metilación de las muestras normales en las otras dos regiones reguladoras de genes (hsa-miR124-1 y hsa-miR124-2). En las lesiones de CIN1, el 28% (10/36) mostró metilación en hsa-miR124-1, 6% (2/36) en hsa-miR124-2 y 11% (4/36) en hsa-miR124-3. Los resultados positivos a la metilación en las lesiones CIN3 varió de 46% (19/41) para hsa-miR124-1, 20% (8/41) para hsa-miR124-2 a 10% (4/41) para hsa-miR124-3. Las frecuencias de hsa-miR124-1, hsa-miR124-2 y hsa-miR124-3 como se detectó en SCC fueron 86% (25/29), 83% (24/29) y 72% (21/29), respectivamente. En el caso de AdCa, se detectó la metilación de hsa-miR124-1, hsa-miR124-2 y hsa-miR124-3 en 93% (14/15), 80% (12/15) y 73% (11/15) respectivamente, de estos tumores. Al combinar los tres ensayos de MSP se encontró que la combinación de hsa-miR124-1 y hsa-miR124-2 tiene la más alta sensibilidad combinada y especificidad para ≥CIN3, ya que todas las muestras de epitelio cervical normales son negativas para la prueba, y el 59% de las lesiones CIN3, 93% de SCC y 93% de AdCas son positivos para la prueba. Debe tenerse en cuenta que las frecuencias por encima de las muestras de tejido sólo con umbrales establecidos en una especificidad de 100%. Bajar el umbral aumenta la sensibilidad para CIN3, aunque disminuye la especificidad.
Tabla 2: Cebadores y sondas para análisis de PCR específico de metilación cuantitativo de MIR124-1, MIR124-2 y MIR124-3.
- Cebador directo
- Sonda Cebador inverso Ubica ción del amplic ón Longi tud del ampli cón
- MIR1 24-1
- 5-CGGCGGGGAGGATGTT3’ 5’-CGGCGTTTTTTATTTTT -3’ 5’-ATAAAAAACGACGCGTATACG TACG-3’ 811904 94 bp
- MIR1 24-2
- 5’-GGGTAATTAATTTGGATTT ACGTCGTTAT-3’ 5’-TTTACAACACACGCCT AAA-3’ 5’-CGTAAAAATATAAACGATACG TATACCTACGT-3’ 701838 138 bp
- MIR1 24-3
- 5’-ACGCGGCGAAGACGTTT-3’ 5’-AAAATCCTCGCCCGAA AAACGCGA-3’ 5’-CGAACGACGAACGTCGAAA-3’ 897991 95 bp
Ejemplo 4: metilación de hsa-miR124 en raspado cervical
Para evaluar el valor marcador putativo de la metilación de hsa-miR124 en la práctica clínica, se evaluó hsa-miR124 en raspados cervicales.
Utilizando un diseño de casos y controles anidados de mujeres que participaron en un ensayo de cribado basado en la población, se estudiaron raspados cervicales de mujeres positivas para hrHPV en las que se diagnosticó ≥CIN 2 (incluido 1 carcinoma) dentro de los 18 meses de seguimiento (esto es, casos) frente a las mujeres positivas para hrHPV en las que se diagnosticó CIN 1 máximo en un período de seguimiento de 18 meses (esto es, controles). La metilación de Hsa-miR124-1 se detectó en el 5% de los controles y el 48% de los casos. La metilación de Hsa-miR124-2 estuvo ausente en los controles y se detectó en el 48% de los casos y la metilación de hsa-miR124-3 se detectó en el 5% de los controles y el 24% de los casos. El análisis combinado de hsa-miR124-1 y hsa-miR124-2 detectó controles del 5% y 71% de los casos. Otros ajustes de la configuración de umbral aumentaron las tasas de sensibilidad para CIN3 a >80%, siendo las tasas de especificidad aún aceptables (>50%).
Ejemplo 5: metilación de hsa-miR124 en muestras automuestreadas
Posteriormente, se analizaron muestras cervicovaginales automuestreadas recogidas utilizando ya sea un muestreador VibaBrush (Rovers Medical Devices, Oss, Países Bajos) o Pantarhei (Pantarhei Devices, Zeist, Países Bajos) durante el curso de un estudio prospectivo en el que se envió un total de 45,000 paquetes de automuestreo a las mujeres que, incluso después de un segundo recordatorio, no respondieron a la invitación para el cribado cervical regular (Véase www.trialregister.nl, Trial no.NTR962 (PROHTECT trial)). Aproximadamente un tercio de estas mujeres devolvieron muestras automuestreadas al laboratorio. Estas muestras son apropiadas para el análisis de PCR de HPV (esto es, positivas a la beta-globina PCR) y las pruebas por hrHPV GP5+/6+-PCR producen al menos tantas lesiones ≥CIN2 en esta población que se encuentran mediante cribado regular en una población emparejada de mujeres respondedoras (Gök et al.2010 Brit.Medical J.;340:c1040).
El 55% de las automuestras de mujeres que más tarde fueron diagnosticadas con ≥CIN3 resultaron positivas para cualquiera de los marcadores MIR124, en comparación con sólo el 25% de las mujeres sin evidencia de enfermedad clínicamente significativa en el seguimiento. Estos datos muestran que el análisis de metilación MIR124 en materiales automuestreados es bien factible y mejorará la detección de la enfermedad cervical subyacente de alto grado.
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Claims (1)
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imagen1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11181492 | 2011-09-15 | ||
| EP11181492 | 2011-09-15 | ||
| PCT/NL2012/050645 WO2013039394A1 (en) | 2011-09-15 | 2012-09-13 | Methylation analysis on self-samples as triage tool for hpv-positive women |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2641093T3 true ES2641093T3 (es) | 2017-11-07 |
Family
ID=47144020
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES12783347.3T Active ES2641093T3 (es) | 2011-09-15 | 2012-09-13 | Método de detección del cáncer de cuello uterino inducido por el HPV |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US20150225796A1 (es) |
| EP (1) | EP2756099B1 (es) |
| JP (1) | JP6328051B2 (es) |
| CN (1) | CN104053783A (es) |
| AU (1) | AU2012309226B2 (es) |
| CA (1) | CA2848654C (es) |
| CY (1) | CY1119570T1 (es) |
| DK (1) | DK2756099T3 (es) |
| ES (1) | ES2641093T3 (es) |
| HR (1) | HRP20171411T1 (es) |
| HU (1) | HUE034556T2 (es) |
| LT (1) | LT2756099T (es) |
| PL (1) | PL2756099T3 (es) |
| PT (1) | PT2756099T (es) |
| RS (1) | RS56380B1 (es) |
| SI (1) | SI2756099T1 (es) |
| SM (1) | SMT201700441T1 (es) |
| WO (1) | WO2013039394A1 (es) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9890432B2 (en) | 2012-10-12 | 2018-02-13 | Self-Screen B.V. | PRDM14 and FAM19A4, molecular diagnostic markers for HPV-induced invasive cancers and their high-grade precursor lesions |
| EP2757161A1 (en) * | 2013-01-17 | 2014-07-23 | Splicos | miRNA-124 as a biomarker of viral infection |
| JP2016201999A (ja) * | 2013-08-26 | 2016-12-08 | 北海道公立大学法人 札幌医科大学 | 大腸癌を検出する方法 |
| JP6607444B2 (ja) * | 2014-02-04 | 2019-11-20 | 公立大学法人横浜市立大学 | 子宮頸がんの前がん病変の進行を予測するための方法 |
| EP2974729A1 (en) | 2014-07-17 | 2016-01-20 | Abivax | Quinoline derivatives for use in the treatment of inflammatory diseases |
| CN107148476B (zh) | 2014-10-17 | 2021-06-08 | 科罗拉多大学董事会法人团体 | 头颈部癌症的生物标志物及其使用方法 |
| EP3135768A1 (en) * | 2015-08-26 | 2017-03-01 | Self-screen B.V. | Zic1 and ghsr, molecular diagnostic markers for hpv-induced invasive cancers, nonhpv-induced gynaecological and anogenital cancers and their high-grade precursor lesions |
| EP3744861B1 (en) * | 2017-03-10 | 2023-12-20 | Self-screen B.V. | A methylation classifier for detection of hpv-induced invasive cancers, nonhpv- induced gynaecological and anogenital cancers and their high-grade precursor lesions |
| JP7218887B2 (ja) * | 2017-06-29 | 2023-02-07 | 学校法人藤田学園 | 子宮頸がん検査用検体 |
| CN111212921A (zh) * | 2017-09-29 | 2020-05-29 | 昂科格诺斯蒂克斯有限公司 | 瘤变和癌的风险确定 |
| CN107760788B (zh) * | 2017-12-05 | 2021-03-02 | 武汉艾米森生命科技有限公司 | 一种检测宫颈细胞基因甲基化的核酸组合及试剂盒与应用 |
| WO2020013693A1 (en) * | 2018-07-11 | 2020-01-16 | Stichting Vumc | Urine dna methylation markers for bladder cancer |
| EP3669873A1 (en) | 2018-12-20 | 2020-06-24 | Abivax | Quinoline derivatives for use ine the traeatment of inflammation diseases |
| CN114214415A (zh) * | 2021-12-29 | 2022-03-22 | 广州安必平医药科技股份有限公司 | 一种用于宫颈癌相关基因甲基化检测的引物探针组合及其应用 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009036332A1 (en) * | 2007-09-14 | 2009-03-19 | Asuragen, Inc. | Micrornas differentially expressed in cervical cancer and uses thereof |
| WO2009113859A1 (en) * | 2008-03-13 | 2009-09-17 | Vereniging Voor Christelijk Hoger Onderwijs, Wetenschappelijk Onderzoek En Patiëntenzorg | Cervical screening algorithms |
| HRP20130780T1 (hr) * | 2008-04-14 | 2013-11-08 | Vereniging Voor Christelijk Hoger Onderwijs, Wetenschappelijk Onderzoek En Patiëntenzorg | Mal-promotor i cadm1-promotor metilacije, molekularni dijagnostiäśki marker za invazivne cervikalne karcinome inducirane hpv-om te njihove predmaligne lezije visokog stupnja |
-
2012
- 2012-09-13 RS RS20170925A patent/RS56380B1/sr unknown
- 2012-09-13 HU HUE12783347A patent/HUE034556T2/en unknown
- 2012-09-13 DK DK12783347.3T patent/DK2756099T3/en active
- 2012-09-13 US US14/344,921 patent/US20150225796A1/en not_active Abandoned
- 2012-09-13 ES ES12783347.3T patent/ES2641093T3/es active Active
- 2012-09-13 AU AU2012309226A patent/AU2012309226B2/en not_active Ceased
- 2012-09-13 LT LTEP12783347.3T patent/LT2756099T/lt unknown
- 2012-09-13 EP EP12783347.3A patent/EP2756099B1/en active Active
- 2012-09-13 CA CA2848654A patent/CA2848654C/en active Active
- 2012-09-13 SI SI201231059T patent/SI2756099T1/sl unknown
- 2012-09-13 SM SM20170441T patent/SMT201700441T1/it unknown
- 2012-09-13 JP JP2014530620A patent/JP6328051B2/ja not_active Expired - Fee Related
- 2012-09-13 HR HRP20171411TT patent/HRP20171411T1/hr unknown
- 2012-09-13 CN CN201280055566.3A patent/CN104053783A/zh active Pending
- 2012-09-13 PT PT127833473T patent/PT2756099T/pt unknown
- 2012-09-13 PL PL12783347T patent/PL2756099T3/pl unknown
- 2012-09-13 WO PCT/NL2012/050645 patent/WO2013039394A1/en not_active Ceased
-
2017
- 2017-09-20 CY CY20171100986T patent/CY1119570T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| DK2756099T3 (en) | 2017-10-02 |
| EP2756099A1 (en) | 2014-07-23 |
| RS56380B1 (sr) | 2017-12-29 |
| CY1119570T1 (el) | 2018-03-07 |
| LT2756099T (lt) | 2017-10-10 |
| US20150225796A1 (en) | 2015-08-13 |
| JP2014526907A (ja) | 2014-10-09 |
| AU2012309226B2 (en) | 2017-12-14 |
| CA2848654A1 (en) | 2013-03-21 |
| SMT201700441T1 (it) | 2017-11-15 |
| PT2756099T (pt) | 2017-09-26 |
| HUE034556T2 (en) | 2018-02-28 |
| JP6328051B2 (ja) | 2018-05-30 |
| SI2756099T1 (sl) | 2017-11-30 |
| HRP20171411T1 (hr) | 2017-11-17 |
| WO2013039394A1 (en) | 2013-03-21 |
| AU2012309226A1 (en) | 2014-04-03 |
| CN104053783A (zh) | 2014-09-17 |
| CA2848654C (en) | 2021-07-20 |
| HK1198774A1 (en) | 2015-06-05 |
| EP2756099B1 (en) | 2017-06-28 |
| PL2756099T3 (pl) | 2017-12-29 |
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