Human papillomavirus infection (HPV) causes cancer of the cervix ("mouth of the womb") in women. Before causing cervical cancer, HPV can also lead to pre-cancer signs that can be detected by cervical cancer screening. Once detected, this pre-cancer can easily be treated before it becomes potentially life-threatening cancer. This pre-cancer is known to exist in several severities, also called "grades". Pre-cancer grade I (one) is the least severe form whereas pre-cancer grade III (three) is the closest grade before cervical cancer.
This study aims at documenting the number / incidence (i.e., new cases) of pre-cancer (also called "Cervical Intraepithelial Neoplasia" (CIN) lesions) of all grades (i.e., grade I, II or III) in a sample of the UK population. It also aims at estimating resource use associated with follow-up and treatment of CIN1 and/or CIN of all grades. Examples of "resource use" are: number of visits to the GP or gynaecologist, number of treatments given, number of medications taken, etcetera.
Additionally, potential progression from grade I to grade CIN II or III will be described as it could help to estimate the impact of treating HPV infections that may lead to grade II or III cervical lesions.
The aim of this study is to estimate the incidence of CIN lesions (All grade, Grade I, II or III) among women aged 18 years and above in the UK subjects contained the CRPD database (data release version Q2 2018 or newer), the CPRD-Linked HES Admitted Patient Care and the CPRD-Linked ONS data. The period of analysis will range from January 1st, 2000 to December 31st, 2017. Incidence will be estimated by year and age category. In addition, time of evolution of CIN lesions from the first CIN obtained to the last CIN obtained will be assessed by evaluating time between new CIN episodes and the one previously reported. Finally the number of healthcare visits/use during 2 years after the first diagnosis of a CIN will be tabulated to evaluate the burden of disease linked to the infection.
Primary health outcomes:
- new Cervical Intraepithelial Neoplasia (CIN) all grades
- new Cervical Intraepithelial Neoplasia Grade 1 (CIN I)
- new Cervical Intraepithelial Neoplasia Grade 2 (CIN II)
- new Cervical Intraepithelial Neoplasia Grade 3 (CIN III)
Secondary health outcomes:
- duration between the 1st CIN (I, II or III) and the last reported CIN (I, II, III or unspecified)
- CIN (All grades) related hospitalisations or GP visits
- CIN related resources use (interventions/treatment)
Georges Van Kriekinge - Chief Investigator - GlaxoSmithKline Biologicals SA (Belgium)
Emmanuel ARIS - Corresponding Applicant - GlaxoSmithKline Biologicals SA (Belgium)
Germain Lonnet - Collaborator - GSK
Nathalie Servotte - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
HES Admitted Patient Care;ONS Death Registration Data