Cervical CancerNCT03137563
Acceptability of HPV-self Sampling
An observational study of Cervical Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- questionnaire
- How many people
- 356 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2017to 30 Jul 2019
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women attending 8 centers of the Departments of Hearault and Aude : social medical cares, Department of gynecology in the hospitals of Montpellier and Carcassonne ; mid-wifes consultations.
Who may be able to join
- Women 25-65 years old
- Living in the Aude or Herault departments
- Informed patient Exclusion criteria
- Virgins
- Previous hysterectomy
- Present or previous cervical pathology
- Patient under guardianship or tutorship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Acceptability of HPV Self-sampling Among French Women Eligible for Cervical Cancer Screening
This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling.
These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations
Read the detailed description
Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the Region of Occitanie in the south of France).The questionnaire will be proposed to the women attending one of these eight centers by an investigator, who will verify the inclusion and exclusion criteria. The same person will collect the filled questionnaire.
The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability of HPV self-sampling and socio-economic determinants.
These questionnaires will be collected and statistical analysis will be performed using appropriate tools.
This study will bring informations on the acceptibility of HPV self sampling among french women eligible for cervical cancer screening in 2 Departements of the South of France. Self-sampling acceptability will be linked to socio-economic determinants.
These data will be important to propose and evaluate new strategies to improve screening coverage, particularly of the context of the organized cervical cancer screening that will take place in France in 2018.
- Conditions
- Cervical Cancer
- Being tested
- questionnaire
- Keywords
- Women, 25-65 years
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called Distribution of an anonymous questionnaire
The questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Women eligible for cervical cancer screening | French women aged 25 to 65 years living in the Department of Hérault or Aude (France), attending one of the 8 centers where the questionnaire will be distributed Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
accept HPV self-sampling for cervical cancer
Response " Yes " or " No " to the question " would you accept HPV self-sampling for cervical cancer screening ?
Measured: 1 day
Secondary outcomes (1)
Socioeconomic determinants of the response
Socioeconomic determinants of the response " yes " or " no " to the question " would you accept HPV self-sampling for cervical cancer screening ?
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start15 May 2017
- Primary completion30 Jul 2017
- Study completion30 Jul 2019
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 Cervical CancerStudies of the same condition, open and under way.
- 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
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Dépistages34 (Montpellier - France), Adoc11 (Carcassonne - France), Maison médicale Paul Valéry - Union Languedoc Mutualité - (Montpellier -France)
- Responsible party
- Sponsor
- Investigators
- Nathalie BOULLE, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137563
- Sponsor's protocol ID
- UF9839
- Status last verified
- Dec 2020
- First submitted
- 28 Apr 2017
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertucci M, Bonnet E, Satger L, Kreiche A, Chappert JL, Loy-Morel S, Segondy M, Daures JP, Boulle N. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Women Health. 2021 Jan;61(1):83-94. doi: 10.1080/03630242.2020.1831683. Epub 2020 Oct 26.
PubMed 33106125
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability of HPV Self-sampling Among French Women Eligible for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT03137563
- Acronym / sponsor ID
- UF9839
- Conditions
- Cervical Cancer
- Keywords
- Women, 25-65 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Dépistages34 (Montpellier - France), Adoc11 (Carcassonne - France), Maison médicale Paul Valéry - Union Languedoc Mutualité - (Montpellier -France)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 2 May 2017 (actual)
- 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 trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling.
These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations
Detailed description
Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the Region of Occitanie in the south of France).The questionnaire will be proposed to the women attending one of these eight centers by an investigator, who will verify the inclusion and exclusion criteria. The same person will collect the filled questionnaire.
The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability of HPV self-sampling and socio-economic determinants.
These questionnaires will be collected and statistical analysis will be performed using appropriate tools.
This study will bring informations on the acceptibility of HPV self sampling among french women eligible for cervical cancer screening in 2 Departements of the South of France. Self-sampling acceptability will be linked to socio-economic determinants.
These data will be important to propose and evaluate new strategies to improve screening coverage, particularly of the context of the organized cervical cancer screening that will take place in France in 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women eligible for cervical cancer screening | – | Other: questionnaireFrench women aged 25 to 65 years living in the Department of Hérault or Aude (France), attending one of the 8 centers where the questionnaire will be distributed |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women attending 8 centers of the Departments of Hearault and Aude : social medical cares, Department of gynecology in the hospitals of Montpellier and Carcassonne ; mid-wifes consultations.
Key inclusion criteria (7 listed)
- Women 25-65 years old
- Living in the Aude or Herault departments
- Informed patient Exclusion criteria
- Virgins
- Previous hysterectomy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| questionnaireAlso: Distribution of an anonymous questionnaireThe questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria. | Other | Women eligible for cervical cancer screening |
Primary outcome
accept HPV self-sampling for cervical cancer
Time frame: 1 day
Response " Yes " or " No " to the question " would you accept HPV self-sampling for cervical cancer screening ?
1 secondary outcome
Socioeconomic determinants of the response
Time frame: 1 day
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 31 Dec 2020.
- Results publication: PubMed 33106125Bertucci M, Bonnet E, Satger L, Kreiche A, Chappert JL, Loy-Morel S, Segondy M, Daures JP, Boulle N. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Women Health. 2021 Jan;61(1):83-94. doi: 10.1080/03630242.2020.1831683. Epub 2020 Oct 26.
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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.
Nathalie BOULLE, MD, PhD study director
University Hospital, Montpellier
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 Cervical Cancer, run by University Hospital, Montpellier 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 7 inclusion and 0 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 31 Dec 2020. 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?
accept HPV self-sampling for cervical cancer (time frame: 1 day). 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 NCT03137563, 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 31 Dec 2020.