Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary TestPapU-APVNCT02137694
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer
A study testing vaginal auto-takings and urinary test in people with Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test, run by University Hospital, Brest at 2 sites in France.
Trial summary
Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
- What is being tested?
- vaginal auto-takings and urinary test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2014to Oct 2016
- Phase
- Interventional
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest
Who cannot join
- Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Brest
Brest, France, 29609
Hôpital Ferdinand Grall
Landerneau, France, 29800
About this study
Official title: Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.
Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .
- Being tested
- vaginal auto-takings and urinary test
- Keywords
- Papillomavirus, Vaginal auto-takings, Urinary test
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal auto-takings and urinary testOther
vaginal auto-takings and urinary test
| Study group | Role | What they receive |
|---|---|---|
| PapU-APV | Other | No drug and no placebo will be used in this study. For the study participants, only their medical history data and vaginal auto-takings ( APV) and urinary will be collected. Receives: Other: vaginal auto-takings and urinary test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research for human Papillomavirus by vaginal auto-takings and urinary test
Estimate the research for human Papillomavirus ( HPV) in the vaginal auto-takings ( APV) and urinary ( APU) test at women from 25 to 65 years old requiring a screening.
Measured: 6 months
Secondary outcomes (1)
The global logistic of the study
Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary TestStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher PAYAN, PU-PH, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137694
- Sponsor's protocol ID
- RB 13.161 PapU-APV
- Acronym
- PapU-APV
- Status last verified
- Dec 2015
- First submitted
- 30 Apr 2014
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.
- ClinicalTrials.gov ID
- NCT02137694
- Acronym / sponsor ID
- PapU-APV / RB 13.161 PapU-APV
- Keywords
- Papillomavirus, Vaginal auto-takings, Urinary test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 May 2014 (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.
Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PapU-APV | Other | Other: vaginal auto-takings and urinary testNo drug and no placebo will be used in this study. For the study participants, only their medical history data and vaginal auto-takings ( APV) and urinary will be collected. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest
Key exclusion criteria (1 listed)
- Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.
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 |
|---|---|---|
| vaginal auto-takings and urinary testvaginal auto-takings and urinary test | Other | PapU-APV |
Primary outcome
Research for human Papillomavirus by vaginal auto-takings and urinary test
Time frame: 6 months
Estimate the research for human Papillomavirus ( HPV) in the vaginal auto-takings ( APV) and urinary ( APU) test at women from 25 to 65 years old requiring a screening.
1 secondary outcome
The global logistic of the study
Time frame: 6 months
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 12 Jan 2017.
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.
Christopher PAYAN, PU-PH principal investigator
CHRU BREST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal auto-takings and urinary test in people with Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test, run by University Hospital, Brest at 2 sites 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 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Research for human Papillomavirus by vaginal auto-takings and urinary test (time frame: 6 months). 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 12 Jan 2017.