Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway

GlaxoSmithKline410 enrolled

Overview

This is a register-based, epidemiological study of HPV type distribution in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive carcinomas. This study will involve data collection from different databases in the Cancer Registry of Norway.

This protocol posting has been updated following Protocol Amendment 1 (02 April 2010). The sections impacted are: enrolment, outcome measures and eligibility criteria.

Study Type

OBSERVATIONAL

Enrollment

410

Conditions

Infections, Papillomavirus

Interventions

Cancer Registry of Norway (database)PROCEDURE

Review of database to identify women with primary conization presenting with high grade lesions/ microinvasive cervical carcinomas. Recurrent cones with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer will be identified for all women with primary cones.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: All subjects must meet the following criteria at study entry: * Women aged 18 years and above at the time of the collection of the primary cone specimen; * Who have undergone for the first time a conization due to high grade lesions or microinvasive cervical carcinomas, histologically diagnosed in 2003, with possible extension backwards in time; * Availability of recurrent cone specimen with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer; * Availability in designated local laboratories of the primary and recurrent cone specimens; * The cone specimen was adequately preserved; * Written informed consent obtained from the subject. If the subject is deceased, the cone and biopsy specimens will be used according to prior approval from the Ethics Committee. Exclusion Criteria: None.

Locations (1)

GSK Investigational Site

Bergen, Norway

Outcomes

Primary Outcomes

HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.

Time frame: At the end of the study.

HPV-types as single group considered as persistent infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.

Time frame: At the end of the study.

Secondary Outcomes

HPV-types as individual types or as different groups considered as new infections in recurrent conizations presenting high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.

Time frame: At the end of the study.

HPV-types as individual types or as different groups considered as persistent infections in recurrent conizations presenting high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.

Time frame: At the end of the study.

Data from ClinicalTrials.gov

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