HPV InfectionEpi-STARTNCT02809352
Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer
An observational study of HPV Infection, run by CHU de Reims at 1 site in France.
Trial summary
Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. Read more about this study
- Who is it for?
- Ages 31 to 65 years, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- Human papillomavirus genotyping
- How many people
- 348 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Dec 2014
- 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 31 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who participate in START-HPV pilot screening program and tested positive for high-risk HPV
Who may be able to join
- to live in the Ardennes department (France)
- affiliation to a health insurance organism
- 31 to 65 years old
Who cannot join
- current follow-up for cervical cytological abnormalities
- history of hysterectomy
- reimbursement for a Pap smear in the last 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)
Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.
- Conditions
- HPV Infection
- Being tested
- Human papillomavirus genotyping
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human papillomavirus genotypingBiological
| Study group | Role | What they receive |
|---|---|---|
| women tested positive for hrHPV | All women participating in START-HPV pilot program for cervical cancer screening and tested positive for hrHPV with the Hybrid Capture 2 test (Qiagen). Receives: Biological: Human papillomavirus genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV genotyping
DNA extraction from cervical smears (DNAPap Cervical Sampler device, Qiagen) or from self-collected vaginal lavages (Delphi-screener device, DelphiBioscience) and HPV genotyping with the Multiplex HPV Genotyping kit© (Multimetrix, Progen) based on a Luminex technology
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2012
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809352
- Sponsor's protocol ID
- PJ12078
- Acronym
- Epi-START
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)
- ClinicalTrials.gov ID
- NCT02809352
- Acronym / sponsor ID
- Epi-START / PJ12078
- Conditions
- HPV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- First posted
- 22 Jun 2016 (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.
Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women tested positive for hrHPV | – | Biological: Human papillomavirus genotypingAll women participating in START-HPV pilot program for cervical cancer screening and tested positive for hrHPV with the Hybrid Capture 2 test (Qiagen). |
Who may qualify
- Ages
- 31 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who participate in START-HPV pilot screening program and tested positive for high-risk HPV
Key inclusion criteria (3 listed)
- to live in the Ardennes department (France)
- affiliation to a health insurance organism
- 31 to 65 years old
Key exclusion criteria (3 listed)
- current follow-up for cervical cytological abnormalities
- history of hysterectomy
- reimbursement for a Pap smear in the last 3 years
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 |
|---|---|---|
| Human papillomavirus genotyping | Biological | women tested positive for hrHPV |
Primary outcome
HPV genotyping
Time frame: Day 0
DNA extraction from cervical smears (DNAPap Cervical Sampler device, Qiagen) or from self-collected vaginal lavages (Delphi-screener device, DelphiBioscience) and HPV genotyping with the Multiplex HPV Genotyping kit© (Multimetrix, Progen) based on a Luminex technology
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 23 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HPV Infection, run by CHU de Reims at 1 site in France.
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 3 inclusion and 3 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 23 Jun 2016. 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 France. 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?
HPV genotyping (time frame: Day 0). 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 23 Jun 2016.