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This complex study included a pilot and a main part. As the results of the pilot study were satisfying and conclusive, the main study was not performed.
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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.
This protocol posting has been updated following Protocol Amendment 1 (02 April 2010). The sections impacted are: enrolment, outcome measures and eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Registry of Norway (database) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
All subjects must meet the following criteria at study entry:
Exclusion Criteria:
None.
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Women aged 18 years and above registered in the Cancer Registry of Norway.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bergen | 5053 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24631451 | Derived | Vintermyr OK, Iversen O, Thoresen S, Quint W, Molijn A, de Souza S, Rosillon D, Holl K. Recurrent high-grade cervical lesion after primary conization is associated with persistent human papillomavirus infection in Norway. Gynecol Oncol. 2014 May;133(2):159-66. doi: 10.1016/j.ygyno.2014.03.004. Epub 2014 Mar 11. |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| At the end of the study. |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |