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

Terminated

• Conditions: Infections, Papillomavirus
• Interventions: Procedure: Cancer Registry of Norway (database)

• Registration Number: NCT00924794
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Study Start: 2010-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 410

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Cancer Registry of Norway (database)	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.

Primary Outcome Measures

Name	Time	Method
HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.	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.	At the end of the study.

Secondary Outcome Measures

Name	Time	Method
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.	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.	At the end of the study.

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇴 Bergen, Norway