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Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study

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Harvard

Bonde, J, Floore, A, Ejegod, D, Vink, FJ, Hesselink, A, van de Ven, PM, Oštrbenk Valenčak, A, Pedersen, H, Doorn, S, Quint, WG, Petry, KU, Poljak, M, Stanczuk, G, Cuschieri, K, de Sanjosé, S, Bleeker, M, Berkhof, J, Meijer, CJLM, Heideman, DAM, Alcaniz, E, Rothe, B, Hortal, MT, Del Pino, M & Bhatia, R 2021, 'Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study', International Journal of Cancer, bind 148, nr. 2, s. 396-405. https://doi.org/10.1002/ijc.33320

APA

Bonde, J., Floore, A., Ejegod, D., Vink, F. J., Hesselink, A., van de Ven, P. M., Oštrbenk Valenčak, A., Pedersen, H., Doorn, S., Quint, W. G., Petry, K. U., Poljak, M., Stanczuk, G., Cuschieri, K., de Sanjosé, S., Bleeker, M., Berkhof, J., Meijer, C. J. L. M., Heideman, D. A. M., ... Bhatia, R. (2021). Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study. International Journal of Cancer, 148(2), 396-405. https://doi.org/10.1002/ijc.33320

CBE

Bonde J, Floore A, Ejegod D, Vink FJ, Hesselink A, van de Ven PM, Oštrbenk Valenčak A, Pedersen H, Doorn S, Quint WG, Petry KU, Poljak M, Stanczuk G, Cuschieri K, de Sanjosé S, Bleeker M, Berkhof J, Meijer CJLM, Heideman DAM, Alcaniz E, Rothe B, Hortal MT, Del Pino M, Bhatia R. 2021. Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study. International Journal of Cancer. 148(2):396-405. https://doi.org/10.1002/ijc.33320

MLA

Vancouver

Author

Bonde, Jesper ; Floore, Arno ; Ejegod, Ditte ; Vink, Frederique J ; Hesselink, Albertus ; van de Ven, Peter M ; Oštrbenk Valenčak, Anja ; Pedersen, Helle ; Doorn, Saskia ; Quint, Wim G ; Petry, K Ulrich ; Poljak, Mario ; Stanczuk, Grazyna ; Cuschieri, Kate ; de Sanjosé, Silvia ; Bleeker, Maaike ; Berkhof, Johannes ; Meijer, Chris J L M ; Heideman, Daniëlle A M ; Alcaniz, Elia ; Rothe, Beate ; Hortal, Montserrat Torres ; Del Pino, Marta ; Bhatia, Ramya. / Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women : A large European multicenter study. I: International Journal of Cancer. 2021 ; Bind 148, Nr. 2. s. 396-405.

Bibtex

@article{7e1063dfce1b45698fa6bb1725183ff6,
title = "Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study",
abstract = "In human papillomavirus (HPV) cervical cancer screening, cytology is used as triage to counter the low specificity of HPV testing. VALID-SCREEN is a EU-multicenter, retrospective study conducted to evaluate the clinical performance of the FAM19A4/miR124-2 methylation-based molecular triage test as a substitute or addition to cytology as reflex testing of HPV screen positive women. FAM19A4/miR124-2 methylation test (QIAsure Methylation Test) was evaluated in 2384 HPV-positive cervical screening samples, from women 29-76 years of age, derived from four EU countries. Specimens were collected in ThinPrep or SurePath media, HPV-status, concurrent cytology, and histology diagnosis were provided by the parent institutes. The control population consisted of women with no evidence of disease within 2 years of follow-up. A total of 899 histologies were retrieved; 527 showed no disease, 124 CIN2 (5.2%), 228 CIN3 (9.6%) and 20 cervical cancers (0.8%); 19 of 20 screen-detected cervical cancers were found methylation-positive (sensitivity 95%). Overall specificity of FAM19A4/miR124-2 methylation test was 78.3% (n = 2013; 95%CI: 76-80). The negative predictive value of hrHPV positive, methylation-negative outcomes were 99.9% for cervical cancer (N = 1694; 95%CI: 99.6-99.99), 96.9% for ≥CIN3 (95%CI: 96-98), and 93.0% for ≥CIN2 (95%CI: 92-94). Overall sensitivity for CIN3 using FAM19A4/miR124-2 methylation test was 77% (n = 228; 95%CI: 71-82). CIN3 sensitivity was uniform between centers independent of sample collection medias, DNA extraction methods and HPV screening tests. Being objectively reported compared to the subjectivity of cytology, equally performing across settings and screening methods, the FAM19A4/miR124-2 methylation constitute an alternative/supplement to cytology as triage method to be investigated in real-life pilot implementation.",
keywords = "biomarker, cervical carcinoma, cervical screening, DNA hypermethylation, human genome methylation, human papillomavirus",
author = "Jesper Bonde and Arno Floore and Ditte Ejegod and Vink, {Frederique J} and Albertus Hesselink and {van de Ven}, {Peter M} and {O{\v s}trbenk Valen{\v c}ak}, Anja and Helle Pedersen and Saskia Doorn and Quint, {Wim G} and Petry, {K Ulrich} and Mario Poljak and Grazyna Stanczuk and Kate Cuschieri and {de Sanjos{\'e}}, Silvia and Maaike Bleeker and Johannes Berkhof and Meijer, {Chris J L M} and Heideman, {Dani{\"e}lle A M} and Elia Alcaniz and Beate Rothe and Hortal, {Montserrat Torres} and {Del Pino}, Marta and Ramya Bhatia",
note = "{\textcopyright} 2020 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.",
year = "2021",
month = jan,
day = "15",
doi = "10.1002/ijc.33320",
language = "English",
volume = "148",
pages = "396--405",
journal = "International Journal of Cancer",
issn = "0020-7136",
publisher = "JohnWiley & Sons, Inc",
number = "2",

}

RIS

TY - JOUR

T1 - Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women

T2 - A large European multicenter study

AU - Bonde, Jesper

AU - Floore, Arno

AU - Ejegod, Ditte

AU - Vink, Frederique J

AU - Hesselink, Albertus

AU - van de Ven, Peter M

AU - Oštrbenk Valenčak, Anja

AU - Pedersen, Helle

AU - Doorn, Saskia

AU - Quint, Wim G

AU - Petry, K Ulrich

AU - Poljak, Mario

AU - Stanczuk, Grazyna

AU - Cuschieri, Kate

AU - de Sanjosé, Silvia

AU - Bleeker, Maaike

AU - Berkhof, Johannes

AU - Meijer, Chris J L M

AU - Heideman, Daniëlle A M

AU - Alcaniz, Elia

AU - Rothe, Beate

AU - Hortal, Montserrat Torres

AU - Del Pino, Marta

AU - Bhatia, Ramya

N1 - © 2020 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.

PY - 2021/1/15

Y1 - 2021/1/15

N2 - In human papillomavirus (HPV) cervical cancer screening, cytology is used as triage to counter the low specificity of HPV testing. VALID-SCREEN is a EU-multicenter, retrospective study conducted to evaluate the clinical performance of the FAM19A4/miR124-2 methylation-based molecular triage test as a substitute or addition to cytology as reflex testing of HPV screen positive women. FAM19A4/miR124-2 methylation test (QIAsure Methylation Test) was evaluated in 2384 HPV-positive cervical screening samples, from women 29-76 years of age, derived from four EU countries. Specimens were collected in ThinPrep or SurePath media, HPV-status, concurrent cytology, and histology diagnosis were provided by the parent institutes. The control population consisted of women with no evidence of disease within 2 years of follow-up. A total of 899 histologies were retrieved; 527 showed no disease, 124 CIN2 (5.2%), 228 CIN3 (9.6%) and 20 cervical cancers (0.8%); 19 of 20 screen-detected cervical cancers were found methylation-positive (sensitivity 95%). Overall specificity of FAM19A4/miR124-2 methylation test was 78.3% (n = 2013; 95%CI: 76-80). The negative predictive value of hrHPV positive, methylation-negative outcomes were 99.9% for cervical cancer (N = 1694; 95%CI: 99.6-99.99), 96.9% for ≥CIN3 (95%CI: 96-98), and 93.0% for ≥CIN2 (95%CI: 92-94). Overall sensitivity for CIN3 using FAM19A4/miR124-2 methylation test was 77% (n = 228; 95%CI: 71-82). CIN3 sensitivity was uniform between centers independent of sample collection medias, DNA extraction methods and HPV screening tests. Being objectively reported compared to the subjectivity of cytology, equally performing across settings and screening methods, the FAM19A4/miR124-2 methylation constitute an alternative/supplement to cytology as triage method to be investigated in real-life pilot implementation.

AB - In human papillomavirus (HPV) cervical cancer screening, cytology is used as triage to counter the low specificity of HPV testing. VALID-SCREEN is a EU-multicenter, retrospective study conducted to evaluate the clinical performance of the FAM19A4/miR124-2 methylation-based molecular triage test as a substitute or addition to cytology as reflex testing of HPV screen positive women. FAM19A4/miR124-2 methylation test (QIAsure Methylation Test) was evaluated in 2384 HPV-positive cervical screening samples, from women 29-76 years of age, derived from four EU countries. Specimens were collected in ThinPrep or SurePath media, HPV-status, concurrent cytology, and histology diagnosis were provided by the parent institutes. The control population consisted of women with no evidence of disease within 2 years of follow-up. A total of 899 histologies were retrieved; 527 showed no disease, 124 CIN2 (5.2%), 228 CIN3 (9.6%) and 20 cervical cancers (0.8%); 19 of 20 screen-detected cervical cancers were found methylation-positive (sensitivity 95%). Overall specificity of FAM19A4/miR124-2 methylation test was 78.3% (n = 2013; 95%CI: 76-80). The negative predictive value of hrHPV positive, methylation-negative outcomes were 99.9% for cervical cancer (N = 1694; 95%CI: 99.6-99.99), 96.9% for ≥CIN3 (95%CI: 96-98), and 93.0% for ≥CIN2 (95%CI: 92-94). Overall sensitivity for CIN3 using FAM19A4/miR124-2 methylation test was 77% (n = 228; 95%CI: 71-82). CIN3 sensitivity was uniform between centers independent of sample collection medias, DNA extraction methods and HPV screening tests. Being objectively reported compared to the subjectivity of cytology, equally performing across settings and screening methods, the FAM19A4/miR124-2 methylation constitute an alternative/supplement to cytology as triage method to be investigated in real-life pilot implementation.

KW - biomarker

KW - cervical carcinoma

KW - cervical screening

KW - DNA hypermethylation

KW - human genome methylation

KW - human papillomavirus

UR - http://www.scopus.com/inward/record.url?scp=85092905660&partnerID=8YFLogxK

U2 - 10.1002/ijc.33320

DO - 10.1002/ijc.33320

M3 - Journal article

C2 - 32997803

VL - 148

SP - 396

EP - 405

JO - International Journal of Cancer

JF - International Journal of Cancer

SN - 0020-7136

IS - 2

ER -

ID: 60979167