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

GlaxoSmithKline (GSK)

Status: Terminated

Conditions: Infections, Papillomavirus

Treatments: Procedure: Cancer Registry of Norway (database)

Study type: Observational

Funder types: Industry

Identifiers

NCT00924794

112674

Details and patient eligibility

About

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.

Full description

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

Enrollment: 410 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

410 participants in 1 patient group

Cohort A

Description:

Women aged 18 years and above, diagnosed with high grade lesions or microinvasive cervical carcinomas in primary conization performed and registered in the Cancer Registry of Norway, and presenting with recurrent conization with high grade lesions or microinvasive cervical carcinoma or invasive cervical carcinoma.

Treatment:

Procedure: Cancer Registry of Norway (database)