Last updated: 11/03/2018 13:24:02
Study of natural history of human papillomavirus (HPV) infections in adult women with recurrent conizations in Norway
GSK study ID
112674
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Discontinued
Discontinued
Trial overview
Official title: A retrospective epidemiological study of natural history of HPV infections in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive cervical carcinomas, in Norway
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: At the end of the study.
Interventions:
Procedure/surgery: Cancer Registry of Norway (database)
Enrollment:
410
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
June 2010 to August 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- 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;
- None.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
All subjects must meet the following criteria at study entry:
Exclusion criteria:
- None.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Discontinued
Actual primary completion date
Not applicable
Actual study completion date
2010-20-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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