Korelace mezi integrací genomu vysoce rizikových HPV do lidské DNA detekované molekulárním combingem a závažností cervikální léze: První výsledky EXPL-HPV-002 studie

Translated title of the contribution: Correlation between integration of high--risk HPV genome into human DNA detected by molecular combing and the severity of cervical lesions: First results of the EXPL-HPV-002 study

S. Bouchilloux, F. Fer, F. Lemée, S. Barradeau, V. Dvorak, S. Kubickova, P. Ventruba, R. Tachezy, M. Trnkova, P. Janda, J. Abscheidt, E. Annibal, D. El Mhali, F. Garcia, M. Kech, G. Pilger, A. Bensimon, Florence Mahé

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: The aim of the EXPL-HPV-002 study is to evaluate the integration of 14 high-risk HPV as a biomarker of the severity and the progression of cervical lesions. Such a „triage biomarker“ would help to reduce the number of unnecessary colposcopies, to avoid over--treatment of lesions that spontaneously regress and to better target the lesions requiring treatment. Design: EXPL-HPV-002 is a prospective, open-label, single arm, GCP study conducted at 2 clinical sites in the Czech Republic. Settings: Investigations centers: Private Gynecology Center, Brno; Gynecological and Obstetrical Clinic, Brno; Genotyping central lab: NRL for Papillomaviruses and polyomaviruses, IHBT, Prague; Histology Central reading: Aeskulab Pathology, Prague; Molecular combing HPV test: Genomic Vision, Bagneux. Methods: From June 2016 to May 2018, 688 patients aged 25–65, referred to colposcopy after an abnormal Pap-smear, were enrolled in the study. Among them 60% were found HPV high-risk. The study is divided in two phases: 1. a cross-sectional phase using data collected at first visit (colposcopy images ± histology, pap-smear for HPV genotyping and molecular combing) to study the association between HPV integration status versus colposcopy and histology grades; 2. a longitudinal phase using data collected in follow-up visits: cytology at 6, 18 and 30 months and colposcopy ± histology at 12, 24 and 36 months. A pap-smear collected at 12, 24 and 36 months allows to perform genotyping and molecular combing. HPV integration status is analyzed in comparison with the evolution of lesions, viral clearance and HPV genotype. HPV genotyping and molecular combing were performed on pap-smear samples in central laboratories. Histology data were reviewed by central reading. Results: The transversal phase of the study is achieved and shows that the HPV integration into the human DNA, monitored by molecular combing, can significantly differentiate normal subjects from women with cervical lesions or cancer. Conclusion: HPV integration into the host genome, monitored by Genomic Vision‘s technology, is a reliable diagnostic biomarker that will greatly help clinicians to improve their medical decision tree.

Translated title of the contributionCorrelation between integration of high--risk HPV genome into human DNA detected by molecular combing and the severity of cervical lesions: First results of the EXPL-HPV-002 study
Original languageCzech
Pages (from-to)84-92
Number of pages9
JournalCeska Gynekologie
Volume84
Issue number2
StatePublished - Jan 1 2019
Externally publishedYes

Keywords

  • Biomarker
  • Cervical cancer
  • Genomic Morse Code
  • HPV diagnostic
  • Molecular combing
  • Viral integration

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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