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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Infections, Papillomavirus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort A

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.

Cancer Registry of Norway (database)

Intervention Type 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.

Interventions

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Cancer Registry of Norway (database)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.