title: Assessment of HPV-mRNA test to predict recurrent disease in patients previously treated for CIN 2/3.
abstract: BACKGROUND
  The use of HPV-mRNA test in the follow-up after LEEP is still matter of debate, with regard to its capacity of prediction relapse.
  
  
  OBJECTIVE
  The aim of the present study is to evaluate the reliability of HPV-mRNA test to predict the residual and recurrent disease, and its accuracy in the follow-up of patients treated for CIN 2/3.
  
  
  METHODS
  Multicenter prospective cohort study. Patients who underwent LEEP after a biopsy diagnosing CIN 2/3 were followed at 3, 6, 12, 24 and 36 months. Each check up included cytology, colposcopy, HPV-DNA test (LiPA) and HPV-mRNA test (PreTect HPV Proofer Kit NorChip). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), of HPV-DNA test and HPV-mRNA test to predict relapse, recurrent and residual disease. Using multiple logistic regression, the statistical significant variables as assessed in univariate analysis were entered and investigated as predictors of relapse disease.
  
  
  RESULTS
  The mRNA-test in predicting a residual disease had a sensitivity of 52% and a NPV of 91%, whereas DNA-test had 100% and 100%, respectively. On the contrary in the prediction of recurrent disease mRNA-test had a sensitivity and a NPV of 73.5% and 97%, whereas DNA-test had 44% and 93%. On the multivariate analysis, age, cytology, HPV DNA and mRNA test achieved the role of independent predictors of relapse.
  
  
  CONCLUSIONS
  HPV-mRNA test has a higher sensitivity and a higher NPV in predicting recurrent disease, for this reason it should be used in the follow-up of patients treated with LEEP for CIN 2/3 in order to individualize the timing of check up.
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Frega
authors.affiliation: Section of Gynecology, Academic Department of Biomedicine and Prevention and Clinical Department of Surgery, Tor Vergata University Hospital, Rome 00133, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Sesti
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Danila
authors.initials: D
authors.lastname: Lombardi
authors.affiliation: Department of Obstetrics and Gynaecology, San Carlo Hospital-IDI IRCCS, Rome 00165, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Votano
authors.affiliation: National Cancer Institute, Department of Gynaecologic Oncology, Aviano 33081, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Sopracordevole
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy. Electronic address: angelicacatalano87@hotmail.it.
authors.forename: Angelica
authors.initials: A
authors.lastname: Catalano
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Giusi Natalia
authors.initials: GN
authors.lastname: Milazzo
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Lombardo
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Assorgi
authors.affiliation: Section of Gynecology, Academic Department of Biomedicine and Prevention and Clinical Department of Surgery, Tor Vergata University Hospital, Rome 00133, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Olivola
authors.affiliation: Section of Gynecology, Academic Department of Biomedicine and Prevention and Clinical Department of Surgery, Tor Vergata University Hospital, Rome 00133, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Chiusuri
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Ricciardi
authors.affiliation: Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, 00189, Italy.
authors.forename: Deborah
authors.initials: D
authors.lastname: French
authors.affiliation: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035-1039, Rome 00189, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Moscarini
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D011446:Prospective Studies; D012333:RNA, Messenger / Q000032:analysis* / Q000235:genetics; D012367:RNA, Viral / Q000032:analysis* / Q000235:genetics; D012008:Recurrence; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000601:surgery / Q000821:virology*
chemical_list: D012333:RNA, Messenger; D012367:RNA, Viral
keywords: CIN 2/3; HPV-mRNA test; Recurrence; Residual disease