Infections, PapillomavirusNCT00924794
Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Cancer Registry of Norway (database)
- Type of treatment
- Surgery or procedure
- How many people
- 410 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 18 years and above registered in the Cancer Registry of Norway.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infections, Papillomavirus
- Being tested
- Cancer Registry of Norway (database)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Registry of Norway (database)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cancer Registry of Norway (database) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.
Measured: 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.
Measured: At the end of the study.
Secondary outcomes (2)
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.
Measured: 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.
Measured: At the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924794
- Sponsor's protocol ID
- 112674
- Status last verified
- Apr 2015
- First submitted
- 18 Jun 2009
- Last updated
- 20 Apr 2015
- Results posted
- No
Publications
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.
PubMed 24631451
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00924794
- Acronym / sponsor ID
- 112674
- Conditions
- Infections, Papillomavirus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 410 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years and above registered in the Cancer Registry of Norway.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Cohort A |
Primary outcome
HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.
Time frame: 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.
Time frame: At the end of the study.
2 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.
Time frame: 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.
Time frame: At the end of the study.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Derived from this study: PubMed 24631451Vintermyr 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis. (time frame: At the end of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.