Status:
TERMINATED
Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
18+ years
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...
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.
Eligibility Criteria
Inclusion
- 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
- None.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00924794
Start Date
June 1 2010
End Date
August 1 2010
Last Update
April 20 2015
Active Locations (1)
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1
GSK Investigational Site
Bergen, Norway, 5053