Normal Uterine Cervical CytologyNCT00526370
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
An observational study of Normal Uterine Cervical Cytology and Uterine Cervical Dysplasia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses. Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear. Read more about this study
- Who is it for?
- Ages 23 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Uterine Cervical Cytology, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Jul 2008
- 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 23 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 women in out-patient gynecological ward in account of cervical cell changes and 50 women in the national screening program for cervical cancer, included by their G.P.
Who may be able to join
- Women with cervical dysplasia been referred to conisation.
- Women invited to cervical screening program and with only normal smear and normal smears in their history.
Who cannot join
- Women not performing the tampon self-test before conisation.
- Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses.
Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.
- Keywords
- self test, PAP smear, tampon test, E6/E7, mRNA, HPV
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Women with at least moderate dysplasia in biopsies from cervix uteri | |
| B | Women with only normal PAP-smears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the HPV test of the material from the tampon self-test
Measured: Spring 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Uterine Cervical CytologyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Hans Svanholm, Head of department, Study director, Region Hospital, Department of Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526370
- Sponsor's protocol ID
- TP07-2351
- Status last verified
- Aug 2008
- First submitted
- 6 Sep 2007
- Last updated
- 13 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
- ClinicalTrials.gov ID
- NCT00526370
- Acronym / sponsor ID
- TP07-2351
- Keywords
- self test, PAP smear, tampon test, E6/E7, mRNA, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Sep 2007 (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 purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses.
Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Women with at least moderate dysplasia in biopsies from cervix uteri |
| B | – | –Women with only normal PAP-smears |
Who may qualify
- Ages
- 23 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 women in out-patient gynecological ward in account of cervical cell changes and 50 women in the national screening program for cervical cancer, included by their G.P.
Key inclusion criteria (2 listed)
- Women with cervical dysplasia been referred to conisation.
- Women invited to cervical screening program and with only normal smear and normal smears in their history.
Key exclusion criteria (2 listed)
- Women not performing the tampon self-test before conisation.
- Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.
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
Sensitivity and specificity of the HPV test of the material from the tampon self-test
Time frame: Spring 2008
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 13 Aug 2008.
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.
Hans Svanholm, Head of department study director
Region Hospital, Department of Pathology
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 Normal Uterine Cervical Cytology and Uterine Cervical Dysplasia, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 2 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 13 Aug 2008. 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 Denmark. 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.
What does the primary outcome measure?
Sensitivity and specificity of the HPV test of the material from the tampon self-test (time frame: Spring 2008). It is what the study was designed to measure, not a finding.
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 13 Aug 2008.