High-risk human papillomavirus (HR-HPV) are causally associated with cervical cancer. Integration of HR-HPV DNA in cellular genomes is considered as a major event in cervical cancer development. Several techniques have been used to evaluate integration of HPV but most of them give an imperfect reflect of HPV physical status. Molecular Combing is a powerful innovative technology which allows direct and high-resolution visualization of HR-HPV genome integration pattern.
The aim of the EXPL-HPV-002 study is to evaluate the integration of 14 HR-HPV (16/18/31/33/35/39/45/51/52/56/58/59/66/68) by Molecular Combing as a biomarker of the severity and/or of the progression of cervical lesions.
The EXPL-HPV-002 prospective multicentric study will enroll about 600 women aged 25-65 in 2 clinical sites in the Czech Republic, referred to colposcopy after an abnormal Pap smear.
The study will be divided into two phases: (1) a transversal phase which will study the association between HPV integration status and colposcopy results and histological grades; (2) a longitudinal phase which is expected to last 36 months. This 2nd phase will study the association between HPV integration status and the progression of the lesion / infection.
HPV genotyping and Molecular Combing will be performed in central labs. All histological data will be analyzed by a central reading.
So far, one clinical site is active, and the first patient has been enrolled in June 2016. To date, 300 patients were enrolled, and about 65% of them are HR-HPV positive.
An interim analysis planned after 6 months evaluated 126 patients.
The EXPL-HPV-002 study will evaluate the diagnostic and prognostic values of HR-HPV integration status detected by Molecular Combing. Integration can prove to be a reliable biomarker that can specifically differentiate between women with a high risk from women with a low risk of developing cervical precancerous lesions or cancer. While the first will require immediate treatment, the other will require appropriate monitoring. Molecular Combing technology, as well as the first results of the interim analysis will be presented.