Human Papillomavirus InfectionNCT00931190
Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia
An observational study of Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia, run by Lund University at 1 site in Sweden.
Trial summary
The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia
- How many people
- 195 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2001to Nov 2005
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 195 women referred for treatment of cervical intraepithelial neoplasia in the cathment area of Umeå university hospital. All women had abnormal smears at enrollment.
Who may be able to join
- Referral to Umeå university hospital for treatment due to abnormal Pap smear.
Who cannot join
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. obstetrics and gynecology, University hospital of Northern Sweden
Umeå, 90185
About this study
Official title: Evaluation of the Use of Human Papillomavirus Persistence for Determination of the Treatment Efficacy Among Women With Cervical Intraepithelial Neoplasia, and for Prediction of Recurrence of Cervical Disease
The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.
Read the detailed description
Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Dysplasia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startFeb 2001
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Society
- Investigators
- Anna Söderlund Strand, PhD, Principal investigator, Dept. medical microbiology, Malmö university hospital, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931190
- Sponsor's protocol ID
- 95-240
- Status last verified
- Sep 2009
- First submitted
- 30 Jun 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Human Papillomavirus Persistence for Determination of the Treatment Efficacy Among Women With Cervical Intraepithelial Neoplasia, and for Prediction of Recurrence of Cervical Disease
- ClinicalTrials.gov ID
- NCT00931190
- Acronym / sponsor ID
- 95-240
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Swedish Cancer Society
- Study start
- Feb 2001
- Study completion
- Nov 2005 (actual)
- First posted
- 2 Jul 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.
The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.
Detailed description
Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 195 women referred for treatment of cervical intraepithelial neoplasia in the cathment area of Umeå university hospital. All women had abnormal smears at enrollment.
Key inclusion criteria (1 listed)
- Referral to Umeå university hospital for treatment due to abnormal Pap smear.
Key exclusion criteria (1 listed)
- Lack of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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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.
Anna Söderlund Strand, PhD principal investigator
Dept. medical microbiology, Malmö university hospital, Malmö, Sweden
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 Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia, run by Lund University at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 15 Sep 2009. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 15 Sep 2009.